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

June 5, 2015 updated by: St George's, University of London

The Effects of Standardized Physical Therapy and Functional Strength Training on Upper Limb Function and Neuromuscular Weakness After Stroke: a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW17 0RE
        • St George's Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Action Research Arm Test (ARAT)
Nine Hole Peg Test (9HPT)

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

August 3, 2006

First Submitted That Met QC Criteria

August 3, 2006

First Posted (Estimate)

August 7, 2006

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 5, 2015

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR070116MA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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