Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366210
Status:
COMPLETED
Last Update Posted:
2014-12-25
First Post:
2006-08-18
Brief Title:
Constraint-Induced Therapy Modified for Rehabilitating Arm Function in Stroke Survivors wPlegic Hands
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Constraint-Induced Therapy Modified for Rehabilitating Arm Function in Stroke Survivors wPlegic Hands
Status:
COMPLETED
Status Verified Date:
2010-08
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 compare modified CI therapy for strokes survivors with very limited function to an alternative package of conventional physical rehabilitation techniques
Detailed Description:
Constraint-Induced Movement therapy or CI therapy is a rehabilitation method based on behavioral neuroscience studies of deafferented monkeys that has been shown in controlled studies to produce large improvements in real-world upper-extremity use in individuals with chronic stroke Up till now survivors of stroke with plegic hands have been excluded from CI therapy protocols whether on a research or clinical basis Such individuals are estimated to make up at least 35 of the population with chronic stroke with residual motor deficit Furthermore there are no other interventions for such individuals that have controlled evidence of efficacy for increasing real-world function Thus these stroke survivors represent a large number of healthcare consumers with limited treatment options
We recently completed a pilot study of a modified form of CI therapy for stroke survivors with plegic hands and obtained surprisingly positive findings Six individuals were enrolled who had a flicker of active movement at the elbow and at the wrist or a finger and 30 of active range of motion at the shoulder Participants received three weeks of CI therapy combined with other modes of therapy for six hours per day The treatment package included tone managementmovement facilitation training of more-impaired arm use using shaping functional task practice restraint of the less-impaired arm in the laboratory and at home as indicated and a package of behavioral methods for transferring gains from the laboratory to the home situation As a group the patients showed a large improvement in more-impaired arm use in daily life after treatment Motor Activity Log or MAL ps 05 Effect Size 15 Improvements in more-impaired arm motor ability as measured by scores on a laboratory motor performance test graded Wolf Motor Function Test gWMFT and standardized clinical examination Fugl-Meyer were also substantial ps 05
Based on these initial findings we propose a randomized controlled clinical trial to rigorously test the efficacy of this modification of CI therapy for rehabilitating arm function in chronic stroke patients with severe upper-extremity impairment To this end 40 survivors of stroke with plegic hands will be randomly assigned to receive the intervention described above or a placebo control procedure of the same duration Control participants will receive either 1 tone management EMG biofeedback and other procedures in alternating blocks for 6 hr daily for 15 consecutive weekdays or 2 usual customary care Measures of arm motor ability gWMFT Fugl-Meyer arm use in daily life MAL accelerometry and quality of life Stroke Impact Scale will be administered to all participants before and after treatment and at long-term If the modified CI therapy participants shows larger improvements in more-impaired arm function than the control group participants this will suggest it is an efficacious treatment and raise hopes of additional recovery for a large group of healthcare consumers with limited treatment options
We recently completed a pilot study of a modified form of CI therapy for stroke survivors with plegic hands and obtained surprisingly positive findings Six individuals were enrolled who had a flicker of active movement at the elbow and at the wrist or a finger and 30 of active range of motion at the shoulder Participants received three weeks of CI therapy combined with other modes of therapy for six hours per day The treatment package included tone managementmovement facilitation training of more-impaired arm use using shaping functional task practice restraint of the less-impaired arm in the laboratory and at home as indicated and a package of behavioral methods for transferring gains from the laboratory to the home situation As a group the patients showed a large improvement in more-impaired arm use in daily life after treatment Motor Activity Log or MAL ps 05 Effect Size 15 Improvements in more-impaired arm motor ability as measured by scores on a laboratory motor performance test graded Wolf Motor Function Test gWMFT and standardized clinical examination Fugl-Meyer were also substantial ps 05
Based on these initial findings we propose a randomized controlled clinical trial to rigorously test the efficacy of this modification of CI therapy for rehabilitating arm function in chronic stroke patients with severe upper-extremity impairment To this end 40 survivors of stroke with plegic hands will be randomly assigned to receive the intervention described above or a placebo control procedure of the same duration Control participants will receive either 1 tone management EMG biofeedback and other procedures in alternating blocks for 6 hr daily for 15 consecutive weekdays or 2 usual customary care Measures of arm motor ability gWMFT Fugl-Meyer arm use in daily life MAL accelerometry and quality of life Stroke Impact Scale will be administered to all participants before and after treatment and at long-term If the modified CI therapy participants shows larger improvements in more-impaired arm function than the control group participants this will suggest it is an efficacious treatment and raise hopes of additional recovery for a large group of healthcare consumers with limited treatment options
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