- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00844870
Exploring New Approaches in Reaching Behavior Post Stroke
February 13, 2009 updated by: University of the Sciences in Philadelphia
Training With or Without Upper Body Restraint During Reaching in Individuals Post Stroke
After 4 weeks of training the hypothesis that the more natural training program would yield greater functional changes was proven correct.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Analysis indicated that both methods improved reaching without trunk use Reaching performance scale (RPS), but the trunk -stabilized group led to more significant changes.
Training under less restrictive conditions associated with Task-Related Training (TRT) (auditory feedback from trunk sensor) as compared to stabilized TRT, led to improved functional and impairment measure scores (WMFT, FM and shoulder flexion).
Conclusion: Fading feedback with both training methods, during extended TRT reaching/grasping practice generally led to some improvements.
However, as demonstrated by impairment and functional outcome measures, using TRT with an auditory feedback signals is a more effective approach than forcing the stabilization of the trunk during rehabilitation of the upper-limb.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individuals all scored between 20 and 44 on the Upper-Arm subsection of the Fugl-Meyer Scale (FM- Poole & Whitney, 1988) and demonstrated some trunk movement during the pretest reaching performance scale measures (RPS, Levin 2006)
Exclusion Criteria:
- Individuals were referred if they had no receptive aphasia, apraxia or other cognitive deficits.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
stabilization training group
|
training of arm function with the trunk stabilized
|
|
Experimental: 2
auditory response training group
|
response to an auditory signal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
WMFT
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
FM and shoulder flexion
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gregory T Thielman, Ed.D, University of the Sciences in Philadelphia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
February 13, 2009
First Submitted That Met QC Criteria
February 13, 2009
First Posted (Estimate)
February 16, 2009
Study Record Updates
Last Update Posted (Estimate)
February 16, 2009
Last Update Submitted That Met QC Criteria
February 13, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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