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Evaluation of Whether Functional Strength Training Can Enhance Motor Recovery of the Upper Limb After Stroke
This study is currently recruiting participants.
Verified by St George's, University of London, August 2006
Sponsored by: St George's, University of London
Information provided by: St George's, University of London
ClinicalTrials.gov Identifier: NCT00360789
  Purpose

The purpose of this study is to test the hypothesis that adding functional strength training to UK conventional therapy improves muscle function and walking than either UK conventional therapy alone or increased intensity of UK conventional therapy.


Condition Intervention Phase
Stroke
Behavioral: Conventional UK physical therapy
Behavioral: Increased intensity of UK conventional physical therapy (PT)
Behavioral: UK conventional PT plus functional strength training
Phase I
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: The Effects of Standardized Physical Therapy and Functional Strength Training on Upper Limb Function and Neuromuscular Weakness After Stroke: a Pilot Study

Further study details as provided by St George's, University of London:

Primary Outcome Measures:
  • Action Research Arm Test (ARAT)
  • Nine Hole Peg Test (9HPT)

Secondary Outcome Measures:
  • peak torque around the elbow joint in elbow flexion and extension
  • grip force
  • pinch force
  • smoothness of movement during turning a cranked wheel
  • reciprocal inneveration of biceps and triceps during turning of a cranked wheel.

Estimated Enrollment: 30
Study Start Date: June 2005
Estimated Study Completion Date: December 2006
Detailed Description:

Neuromuscular weakness occurs frequently after stroke and the processes underlying recovery are still poorly understood. Accepted practice in UK physiotherapy is to avoid training of muscle strength after stroke but there is preliminary evidence that it might be effective.

An observer-blind randomised pilot clinical trial (Phase II). Subjects will be within 3 months of first stroke with some voluntary movement in the paretic upper limb.

A Research Physiotherapist, blinded to measurement, will recruit subjects, allocate subjects to one of three intervention groups using sequentially numbered sealed envelopes containing previously allocated intervention cards and provide interventions. Ten participants will be recruited to each group therefore the trial will recuit 30 participants. The Research Assessor, blinded to intervention allocation will undertake all measurements.

Conventional therapy (control) will be provided as normal for the clinical setting, the additional conventional therapy (experimental 1)or functional strength training (experimental 2) will be provided for one hour, five times a week for six weeks. Subjects in the two experimental groups will also receive the conventional therapy standard in their clinical setting.

Blinded measurement will be made before randomisation, at the end of intervention and 12-weeks thereafter. Primary outcomes are the Action Research Arm Test (ARAT)and the Nine Hole Peg Test (9HPT). The secondary outcomes are peak torque around the elbow joint in elbow flexion and extension, grip force, pinch force, smoothness of movement during turning a cranked wheel and reciprocal inniveration of biceps and triceps during turning of a cranked wheel.

Data will be analysed using descriptive statistics and the estimation of standard deviations will be used to inform a power calculation to estimate sample size for a Phase II randomised controlled trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be between one week and three months after stroke when recruited to the study
  • Have some voluntary muscle activity in the paretic upper limb

Exclusion Criteria:

  • Obvious unilateral visuospatial neglect
  • Upper limb movement deficits attributable to non-stroke pathology
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360789

Contacts
Contact: Valerie M Pomeroy, PhD +44(0)20 8725 5327 v.pomeroy@sgul.ac.uk

Locations
United Kingdom
St George's Hospital NHS Trust Recruiting
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
St George's, University of London
Investigators
Study Chair: Valerie M Pomeroy, PhD St George's, University of London
  More Information

Study ID Numbers: GR070116MA
Study First Received: August 3, 2006
Last Updated: August 3, 2006
ClinicalTrials.gov Identifier: NCT00360789  
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by St George's, University of London:
STROKE REHABILITATION
pHYSICAL THERAPY

Study placed in the following topic categories:
Cerebral Infarction
Asthenia
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009