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Task-Related Training of Arm Use After Stroke

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ClinicalTrials.gov Identifier: NCT00222339
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Information provided by:
University of Melbourne

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date September 22, 2005
Study Start Date  ICMJE February 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Arm and hand function measured using the Motor Assessment Scale and the Chedoke-McMaster Impairment Inventory.
  • Grip and pinch strength measured using dynamometers.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Task-Related Training of Arm Use After Stroke
Official Title  ICMJE Task-Related Training of Arm Use After Stroke: a Randomised Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Behavioral: task-specific training
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00222339
Other Study ID Numbers  ICMJE H2001/01313
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Melbourne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary P Galea, PhD University of Melbourne
PRS Account University of Melbourne
Verification Date December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP