Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360789
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2006-08-03
Brief Title:
Evaluation of Whether Functional Strength Training Can Enhance Motor Recovery of the Upper Limb After Stroke
Sponsor:
St Georges University of London
Organization:
St Georges University of London
Study Overview
Official Title:
The Effects of Standardized Physical Therapy and Functional Strength Training on Upper Limb Function and Neuromuscular Weakness After Stroke a Pilot Study
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the hypothesis that adding functional strength training to UK conventional therapy improves muscle function and walking than either UK conventional therapy alone or increased intensity of UK conventional therapy
Detailed Description:
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 1or 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 ARATand 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
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 1or 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 ARATand 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None