Evaluation of Whether Functional Strength Training Can Enhance Motor Recovery of the Upper Limb After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00360789
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : June 8, 2015
Information provided by:
St George's, University of London

Brief Summary:
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 or disease Intervention/treatment 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 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effects of Standardized Physical Therapy and Functional Strength Training on Upper Limb Function and Neuromuscular Weakness After Stroke: a Pilot Study
Study Start Date : June 2005
Actual Study Completion Date : December 2006

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00360789

United Kingdom
St George's Hospital NHS Trust
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
St George's, University of London
Study Chair: Valerie M Pomeroy, PhD St George's, University of London Identifier: NCT00360789     History of Changes
Other Study ID Numbers: GR070116MA
First Posted: August 7, 2006    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: August 2006

Keywords provided by St George's, University of London:

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases