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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by St George's, University of London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00360789
First received: August 3, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014