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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360789
• Other study ID #: GR070116MA
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 3, 2006
• Last updated: June 5, 2015
• Start date: June 2005
• Est. completion date: December 2006

Study information

• Verified date: August 2006
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Conventional UK physical therapy

• Increased intensity of UK conventional physical therapy (PT)

• UK conventional PT plus functional strength training

Locations

Country	Name	City	State
United Kingdom	St George's Hospital NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm Test (ARAT)
Primary	Nine Hole Peg Test (9HPT)
Secondary	peak torque around the elbow joint in elbow flexion and extension
Secondary	grip force
Secondary	pinch force
Secondary	smoothness of movement during turning a cranked wheel
Secondary	reciprocal inneveration of biceps and triceps during turning of a cranked wheel.