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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
University of Melbourne
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Hand function, Task-specific training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
University of Melbourne
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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

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Task-Related Training of Arm Use After Stroke

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