Task-Related Training of Arm Use After Stroke

Stroke Clinical Trial

Official title:

Task-Related Training of Arm Use After Stroke: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222339
• Other study ID #: H2001/01313
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: February 2002
• Est. completion date: June 2004

Study information

• Verified date: December 2001
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• task-specific training

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
University of Melbourne

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm and hand function measured using the Motor Assessment Scale and the Chedoke-McMaster Impairment Inventory.
Primary	Grip and pinch strength measured using dynamometers.
Secondary	Dexterity measured using the NK Dexterity Board
Secondary	Quality of Life measured using the Stroke-adapted Sickness Impact Profile.
Secondary	Sensation using a validated assessment of tactile spatial resolution.