Task-Related Training of Arm Use After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
task-specific training
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Hand function, Task-specific training
Eligibility Criteria
Inclusion Criteria: within 6 weeks of first stroke unilateral stroke impaired arm function able to cope with intensive training program medically stable able to understand instructions Exclusion Criteria: uncontrolled systemic disease significant musculotendinous or bony restrictions of the affected upper limb any serious chronic disease independently causing significant disability of the affected limb
Sites / Locations
- Austin Health
Outcomes
Primary Outcome Measures
Arm and hand function measured using the Motor Assessment Scale and the Chedoke-McMaster Impairment Inventory.
Grip and pinch strength measured using dynamometers.
Secondary Outcome Measures
Dexterity measured using the NK Dexterity Board
Quality of Life measured using the Stroke-adapted Sickness Impact Profile.
Sensation using a validated assessment of tactile spatial resolution.
Full Information
NCT ID
NCT00222339
First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
University of Melbourne
1. Study Identification
Unique Protocol Identification Number
NCT00222339
Brief Title
Task-Related Training of Arm Use After Stroke
Official Title
Task-Related Training of Arm Use After Stroke: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2001
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Melbourne
4. Oversight
5. Study Description
Brief Summary
Stroke is the leading cause of long-term physical disability in Australia. Currently around 25% of hemiplegic stroke patients discharged from rehabilitation have significantly impaired use of the affected hand with consequent dependence in dressing, grooming and feeding themselves. The poor outcome can be attributed in part to a lack of focus by therapists on the negative signs of stroke (weakness and lack of dexterity) as well as too little time (around 10 minutes per day) being devoted to retraining of the arm. Presently there is a very limited evidence base to guide the content of clinical practice. Results from both animal and human studies suggest that specific post-lesion training can result in substantial improvement in function. The hypothesis is that task-specific training of the affected upper limb to subjects in the early period following stroke will result in significantly better functional outcome than standard intervention.
Detailed Description
Stroke is the leading cause of long-term physical disability in Australia. Currently around 25% of hemiplegic stroke patients discharged from rehabilitation have significantly impaired use of the affected hand with consequent dependence in dressing, grooming and feeding themselves. The poor outcome can be attributed in part to a lack of focus by therapists on the negative signs of stroke (weakness and lack of dexterity) as well as too little time (around 10 minutes per day) being devoted to retraining of the arm. Presently there is a very limited evidence base to guide the content of clinical practice. Results from both animal and human studies suggest that specific post-lesion training modulates physiological changes that take place in undamaged tissue. It is probable that this training induces use-dependent patterns of neural activity that can selectively drive the reorganization of the undamaged cortical areas and thereby improve the functional outcome for the arm and hand. We have developed a task-specific training program for the upper limb that is unique in a) the focus on performance of functional tasks, and b) the intensity of practice, with patients practising the tasks both during and outside of therapy sessions.
Comparisons: A 3-week daily task-specific training of the affected upper limb compared to a control intervention that does not involve upper limb training. Both interventions are additional to the standard rehabilitation program.
Outcomes measured pre- and post-intervention and 3 months follow-up. Outcome measures include: variables grip and pinch force, dexterity, arm use and quality of life. Severity of stroke, classified according to the upper arm sub-test of the Motor Assessment Scale, will be used as a covariate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Hand function, Task-specific training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
task-specific training
Primary Outcome Measure Information:
Title
Arm and hand function measured using the Motor Assessment Scale and the Chedoke-McMaster Impairment Inventory.
Title
Grip and pinch strength measured using dynamometers.
Secondary Outcome Measure Information:
Title
Dexterity measured using the NK Dexterity Board
Title
Quality of Life measured using the Stroke-adapted Sickness Impact Profile.
Title
Sensation using a validated assessment of tactile spatial resolution.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
within 6 weeks of first stroke
unilateral stroke
impaired arm function
able to cope with intensive training program
medically stable
able to understand instructions
Exclusion Criteria:
uncontrolled systemic disease
significant musculotendinous or bony restrictions of the affected upper limb
any serious chronic disease independently causing significant disability of the affected limb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary P Galea, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
12. IPD Sharing Statement
Citations:
Citation
Miller K, Galea M, Kilbreath S, Phillips B (2002) Early intensive task-specific sensory and motor training of the upper limb following acute stroke: a pilot study. In Battistin L, Dam M, Tonin P(eds) Neurological Rehabilitation. Bologna:Mondizzi Editore.
Results Reference
result
Learn more about this trial
Task-Related Training of Arm Use After Stroke
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