Evaluation of Whether Functional Strength Training Can Enhance Motor Recovery of the Upper Limb After Stroke
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00360789|
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : June 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: Conventional UK physical therapy Behavioral: Increased intensity of UK conventional physical therapy (PT) Behavioral: UK conventional PT plus functional strength training||Phase 1 Phase 2|
Neuromuscular weakness occurs frequently after stroke and the processes underlying recovery are still poorly understood. Accepted practice in UK physiotherapy is to avoid training of muscle strength after stroke but there is preliminary evidence that it might be effective.
An observer-blind randomised pilot clinical trial (Phase II). Subjects will be within 3 months of first stroke with some voluntary movement in the paretic upper limb.
A Research Physiotherapist, blinded to measurement, will recruit subjects, allocate subjects to one of three intervention groups using sequentially numbered sealed envelopes containing previously allocated intervention cards and provide interventions. Ten participants will be recruited to each group therefore the trial will recuit 30 participants. The Research Assessor, blinded to intervention allocation will undertake all measurements.
Conventional therapy (control) will be provided as normal for the clinical setting, the additional conventional therapy (experimental 1)or functional strength training (experimental 2) will be provided for one hour, five times a week for six weeks. Subjects in the two experimental groups will also receive the conventional therapy standard in their clinical setting.
Blinded measurement will be made before randomisation, at the end of intervention and 12-weeks thereafter. Primary outcomes are the Action Research Arm Test (ARAT)and the Nine Hole Peg Test (9HPT). The secondary outcomes are peak torque around the elbow joint in elbow flexion and extension, grip force, pinch force, smoothness of movement during turning a cranked wheel and reciprocal inniveration of biceps and triceps during turning of a cranked wheel.
Data will be analysed using descriptive statistics and the estimation of standard deviations will be used to inform a power calculation to estimate sample size for a Phase II randomised controlled trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effects of Standardized Physical Therapy and Functional Strength Training on Upper Limb Function and Neuromuscular Weakness After Stroke: a Pilot Study|
|Study Start Date :||June 2005|
|Actual Study Completion Date :||December 2006|
- Action Research Arm Test (ARAT)
- Nine Hole Peg Test (9HPT)
- peak torque around the elbow joint in elbow flexion and extension
- grip force
- pinch force
- smoothness of movement during turning a cranked wheel
- reciprocal inneveration of biceps and triceps during turning of a cranked wheel.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360789
|St George's Hospital NHS Trust|
|London, United Kingdom, SW17 0RE|
|Study Chair:||Valerie M Pomeroy, PhD||St George's, University of London|