Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322192
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2006-05-04
Brief Title:
Evaluation of Whether Functional Strength Training Can Enhance Recovery of Mobility After Stroke
Sponsor:
St Georges University of London
Organization:
St Georges University of London
Study Overview
Official Title:
The Effects of Functional Strength Training on Weakness and Function of the Lower Limb After Stroke
Status:
COMPLETED
Status Verified Date:
2006-05
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 clinical trial Subjects will be within 3 months of first stroke with some voluntary movement in the paretic lower limb A power calculation estimated the sample size as 300 Research Physiotherapists blinded to measurement will recruit subjects allocate subjects to one of the three intervention groups using sequentially numbered sealed envelopes containing previously randomised allocated intervention cards and provide interventions The Research Assessors 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 four 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 maximum torque around the knee joint and gait velocity The secondary outcomes include movement analysis functional ability corticospinal transmission transcranial magnetic stimulation and health related quality of life Euroqol The primary analysis will be analysis of covariance A multiple comparison procedure Gabriels test will be used to compare each pair of treatments Euroqol data will be used to estimate the relative costs of the interventions and to calculate the incremental cost per QUALY gained Every effort will be made to invite patients for assessment at outcome and follow-up even if they have withdrawn from therapy to allow the intention-to-treat principle to be applied
An observer-blind randomised clinical trial Subjects will be within 3 months of first stroke with some voluntary movement in the paretic lower limb A power calculation estimated the sample size as 300 Research Physiotherapists blinded to measurement will recruit subjects allocate subjects to one of the three intervention groups using sequentially numbered sealed envelopes containing previously randomised allocated intervention cards and provide interventions The Research Assessors 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 four 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 maximum torque around the knee joint and gait velocity The secondary outcomes include movement analysis functional ability corticospinal transmission transcranial magnetic stimulation and health related quality of life Euroqol The primary analysis will be analysis of covariance A multiple comparison procedure Gabriels test will be used to compare each pair of treatments Euroqol data will be used to estimate the relative costs of the interventions and to calculate the incremental cost per QUALY gained Every effort will be made to invite patients for assessment at outcome and follow-up even if they have withdrawn from therapy to allow the intention-to-treat principle to be applied
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Health Foundation 2241960 | None | None | None |