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Periodic Limb Movement

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3161. A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS

is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs). The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues. The urge to move or unpleasant sensations are worse in the evening or night than during (...) Measures : Onset of action on Day 3 as measured by the CGI-I responder rate Onset of action as measured by PGI and modified IRLS score Clinical Global Impression of improvement Patient Global Impression IRLS as a responder rate VAS score for pain in limbs [ Time Frame: 6 weeks ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join

2006 Clinical Trials

3162. Insomnia and Osteoarthritis Study

hours per night Patients taking NSAID therapy for pain must be on a stable dose for a period of at least one month prior to initiating the study Exclusion Criteria: Intrinsic sleep disorders other than insomnia (sleep apnea, periodic limb movement disorder, etc) Significant rheumatologic or chronic pain disorders other than osteoarthritis of the knee, including fibromyalgia or the complaint of widespread pain impacting 4 quadrants, complex regional pain syndrome, post herpetic neuralgia, etc) Major (...) , and 12 week follow-up ] As recorded in daily sleep diary. Visual analog scales (VAS) Sleep Quality Ratings 0-100, 0= extremely poor sleep quality, (shallow and unrefreshing) and 100=excellent sleep quality (deep and refreshing) WASO as Assessed by Actigraphy [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ] Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep

2006 Clinical Trials

3163. Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

category. Percentage of Participants Reporting Pre-specified Local Reactions [ Time Frame: Within 7 days after each dose ] Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant ([Sig.], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate ([Mod.], 2.5 to 7.0 cm); Severe ([Sev.], > 7.0 cm). Participants may have been represented (...) : 42 Days to 98 Days (Child) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Healthy 2-month-old infants. Available for the entire study period. Exclusion criteria: Previous vaccination with any vaccine before the start of the study. Known contraindication to vaccination. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact

2006 Clinical Trials

3164. 12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

: GlaxoSmithKline Information provided by (Responsible Party): GlaxoSmithKline Study Details Study Description Go to Brief Summary: The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep. Condition or disease Intervention/treatment Phase Restless Legs Syndrome (RLS) Restless Legs Syndrome Drug: ropinirole CR-RLS Phase 4 Study Design Go to Layout table (...) for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 39 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment Official Title: A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep Study Start Date

2006 Clinical Trials

3165. Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome

by the investigator) to rule out other sleep disorders (ie, narcolepsy and periodic limb movement with sleep [PLMs]). Have ES (CGI-S [Clinical Global Impression of Severity] ≥4) that is not a direct result of inadequate sleep hygiene or other medical disorder Are in good health as determined by a medical and psychiatric history, physical examination, ECG, and clinical laboratory tests For patients who are not current users of CPAP therapy or who are not appropriately titrated on CPAP: have an average of 5 or more (...) or present seizure disorder (except history of a single febrile seizure), a history of psychosis, or of clinically significant head trauma (eg, brain damage) or past neurosurgery Have periodic limb movement (PLM) arousal index greater than 5 (ie, >5 PLMs with arousals per hour of sleep) Have a history of suicide attempt, or are at suicidal risk A clinically significant drug sensitivity to stimulants such as amphetamine, dextroamphetamine, methylphenidate, or pemoline; and/or modafinil or any of its

2005 Clinical Trials

3166. Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

, inclusive Meet the minimal criteria established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM) for narcolepsy (or presumed narcolepsy) as assessed by all of the following: *clinical history; NPSG (nocturnal polysomnogram) (as evaluated by the investigator) to rule out other sleep disorders (ie, obstructive sleep apnea/hypopnea syndrome [OSAHS] or periodic limb movement with sleep [PLMs]); narcolepsy (or presumed narcolepsy (...) ) as identified by at least 1 of the following: MSLT (as evaluated by the investigator) (mean sleep latency [from 4 naps] <10 minutes); 2 sleep onset REM periods (SOREMP); cataplexy; sleep paralysis; hypnogogic hallucinations -OR- *have a previous diagnosis of narcolepsy on the basis of NPSG and/or MSLT at any time before the screening visit Have ES (MSLT <10 minutes and/or CGI S ≥4) that is not a direct result of inadequate sleep hygiene or other medical disorder Are in good health as determined by a medical

2005 Clinical Trials

3167. Prosthetic Components and Stability in Amputee Gait

of wearing a rigid pylon and after a one-month period of wearing a transverse plane rotation adaptor (within-subject comparison). In addition to these field measurements, we will also compare the distance traveled during a six-minute walk. Patient opinions about their prosthesis and mobility measures over long periods of time can play a significant role in prosthesis evaluation. For veteran amputees who experience discomfort and increased risk for residual limb skin problems, it seems reasonable (...) of prosthetic components to facilitate transverse plane movement. The clinical impact of this investigation is the development of interventions that increase functional mobility, stability and safety while turning. The researchers propose to investigate three sets of hypotheses. The first set addresses the fundamental biomechanical mechanisms associated with walking along a circular trajectory, how intact subjects differ from amputees, and the effect of a rotation adaptor pylon. The second set of hypotheses

2005 Clinical Trials

3168. Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

. After a 2-week baseline period, the subjects undergo a screening sleep study to rule out sleep apnea and periodic limb movement disorder. Then they undergo the NSLP procedure. In that procedure, there pre-bedtime EEG recordings and questionnaire responses taken. Then at a planned time, the subjects go to bed and try to sleep while there EEG signals are recorded. After the first and second sleep cycles, they are awakened for one minute, then asked to return to sleep. In the morning additional

2005 Clinical Trials

3169. Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa / Benserazide (Madopar® DR) in Patients With Restless Legs Syndrome

Per Day) Versus Levodopa / Benserazide (Madopar® DR, 125-375 mg Per Day) in Patients With Restless Legs Syndrome Study Start Date : February 2003 Actual Primary Completion Date : February 2005 Study Completion Date : February 2005 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : Frequency of periodic limb movements while in bed (PLM-I) [ Time Frame: after 4 weeks (...) with idiopathic restless legs syndrome fulfilling the International Diagnostic Criteria. The efficacy parameters include an objective measure of the leg movements during the time spent in bed, and a quantitative clinical assessment of the severity of RLS, in the form of the RLS-score. In addition, the efficacy evaluations aim at comparing the impact of pramipexole and levodopa on outcome measures such as quality of life and sleep. Condition or disease Intervention/treatment Phase Restless Legs Syndrome Drug

2005 Clinical Trials

3170. Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke

enough residual movement to take part in volitional active repetitive movement therapy and does not require expensive equipment or skilled personnel. Two types of NMES are available. The first is cyclic NMES, which electrically activates paretic muscles at a set duty cycle for a preset time period. (This study will employ both "traditional" cyclic stimulation and "sensory-only" stimulation, in which intensity is set at a level to be felt by the patient but insufficient to cause muscle contraction (...) of treatment (week 9); and for follow-up visits at one-, three- and six-months post-treatment. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 122 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment Official Title: Electrical Stimulation for Upper Limb Recovery in Stroke Study Start Date : December 2005 Actual Primary Completion Date : March 2010

2005 Clinical Trials

3171. Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis

Accident Other: Control Other: Experimental Not Applicable Detailed Description: This proposal extends the work accomplished in our initial study (project #B2405R, 'Effects of Strength Training on Upper-limb Function in Post-stroke Hemiparesis'). In the present study we will conduct a double-blind, randomized clinical trial of staged rehabilitation for the upper-extremity involving sequential delivery of functional therapy and high intensity resistance training. Therefore, this proposal directly (...) compares the effects of functional and resistance training delivered individually. The researchers' previous work investigated a hybrid therapy of functional and resistance training against functional training alone. All subjects will participate in a 5 week run-in period of no treatment. This no-treatment block will afford multiple baseline measurements and, in addition, will provide information regarding the rate and magnitude of any spontaneous recovery without treatment. Following the second

2005 Clinical Trials

3172. Provigil (Modafinil) Study by Taiwan Biotech Co.

, or suspected long sleeper. Patients with concomitant neurological disorder and psychiatric disorders. Patients with sleep-related breathing disorders whose apnea/hypopnea index (AHI) was 5 pauses per hour above. Patients with Restless Leg Syndrome & Periodic Limbs Movements whose index was more than 5 per hour. Patients who are pregnant or breast-feeding. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study

2005 Clinical Trials

3173. Functional Electrical Stimulation for Footdrop in Hemiparesis

Institute of Child Health and Human Development (NICHD) Case Western Reserve University Information provided by (Responsible Party): John Chae, MD, MetroHealth Medical Center Study Details Study Description Go to Brief Summary: The objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles, and the walking ability of stroke survivors. The knowledge gained from this study may lead to enhancements in the quality of life (...) of stroke survivors by improving their neurological recovery and mobility. The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke. Condition or disease Intervention/treatment Phase Stroke Hemiplegia Device: Odstock Dropped-Foot Stimulator (ODFS) Other: Conventional Standard of Care Procedure: Traditional Physical Therapy Treatment Not Applicable Detailed Description: Hemiplegia is a major consequence of stroke and contributes

2005 Clinical Trials

3174. Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

borderline personality disorder Substance abuse Not willing to end other psychiatric treatment Previous electroconvulsive therapy or vagus nerve stimulation treatment during the last year Sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after first sleep study) Other sleep disorders Currently pregnant or breastfeeding History of seizure disorder Disease or condition that produces altered metabolism or hemodynamic responses Liver or kidney dysfunction Current use of any over

2005 Clinical Trials

3175. Characteristics of Sleep Patterns in Young Adults With and Without Insomnia

, antianxiety medications or medications for sleep disorders Currently experiencing symptoms of psychiatric disorders such as major depressive disorder, bipolar disorder, generalized anxiety disorder Significant or unstable acute or chronic medical conditions, such as seizure disorder, tumor, liver disease, active peptic ulcer disease, arthritis, irritable bowel disease Meets DSM-IV criteria for sleep apnea or periodic limb movement disorder Contacts and Locations Go to Information from the National Library (...) treatment. Secondary Outcome Measures : Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint [ Time Frame: post treatment minus baseline PSG sleep studies. This averaged 70 days ] Change in PSG Sleep Efficiency (SE) between post-treatment and baseline: Sleep efficiency is the percent of time spent asleep divided by the total sleep recording period in the sleep lab. This value is calculated using the results of the polysomnographic sleep study. It ranges from 0 (no sleep

2005 Clinical Trials

3176. Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome

the Efficacy and Safety of Pramipexole With the Dose Range From 0.125 mg to 0.75 mg Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome. Study Start Date : August 2004 Actual Primary Completion Date : December 2005 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : Primary Endpoint: Decrease in periodic limb movements during time in bed index (PLMI (...) ) in the PSG Secondary Outcome Measures : Total score of RLS severity scale-J by IRLSSG, Periodic Limb Movements during Sleep Index (PLMSI) in the PSG Periodic Limb Movements during Wakefulness Index (PLMWI) in the PSG Periodic Limb Movements in Sleep with Arousal Index (PLMAI) in the PSG ) Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding

2005 Clinical Trials

3177. Ropinirole Tablets In Young Patients With Restless Legs Syndrome

. Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy). [ Time Frame: Up to 3 years ] Secondary Outcome Measures : PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy. [ Time Frame: Up to 3 years ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor (...) : 101468/253 First Posted: September 1, 2005 Last Update Posted: September 11, 2017 Last Verified: September 2017 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. Keywords provided by GlaxoSmithKline: RLS PLMS Adolescent Periodic Limb Movements of Sleep Ropinirole Additional relevant MeSH terms: Layout

2005 Clinical Trials

3178. Efficacy of Voice Treatment for Parkinson's Disease

by (Responsible Party): University of Colorado, Boulder Study Details Study Description Go to Brief Summary: The purpose of the research study is to determine the effects of two different kinds of speech treatment on certain behaviors in individuals with parkinson's disease. These behaviors include speech, voice, related communication behaviors, swallowing and body movement. Condition or disease Intervention/treatment Phase Parkinson's Disease Dysphagia Dysarthria Behavioral: Voice/Respiration Treatment (...) Behavioral: Speech/Articulation Treatment Not Applicable Detailed Description: This is a research project designed to look at various areas of function, such as speech, voice, swallowing, related communication behaviors and body movement of individuals with idiopathic Parkinson disease (PD) and to investigate how two different forms of speech therapy affect these areas. We are asking up to 620 individuals to participate in this study in several different ways. Specifically, there is an experimental group

2005 Clinical Trials

3179. Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use

function by providing natural support to the lower limb as it progresses over the stance foot. However, a fundamental design characteristic of all PD-AFOs is that they are not capable of replicating all dynamic characteristics of the natural ankle complex. As a result, the efficient use of PD-AFOs during gait requires the wearer to develop an adapted, lower limb movement control strategy that effectively optimizes positive PD-AFO characteristics while compensating for characteristics detrimental (...) pictures of their legs, a procedure lasting up to 2 hours. Patients will be asked to return to learn how to walk with the custom Passive Dynamic Ankle-Foot Orthosis (PD-AFO)-a unique ankle brace designed to improve walking ability by providing natural support to the lower limb. Patients 4 and older who are in good health and able to walk repeatedly a distance of 15 meters (approximately 49 feet) independently and unsupervised may be eligible for this study. With this training, patients may return

2005 Clinical Trials

3180. Safety and Efficacy Study of APD125 in Patient With Insomnia

) or a Periodic Limb Movement Arousal Index (PLMAI) > 10 as determined by screening PSG History of treatment with an investigational drug within the last month Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (> 3 time zones) during the study Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor

2007 Clinical Trials

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