NCT00360789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 stroke

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 8, 2015

Status Verified

August 1, 2006

First QC Date

August 3, 2006

Last Update Submit

June 5, 2015

Conditions

Stroke

Keywords

STROKE REHABILITATIONpHYSICAL THERAPY

Outcome Measures

Primary Outcomes (2)

  • Action Research Arm Test (ARAT)

  • Nine Hole Peg Test (9HPT)

Secondary Outcomes (5)

  • 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.

Interventions

Conventional UK physical therapyBEHAVIORAL
Increased intensity of UK conventional physical therapy (PT)BEHAVIORAL
UK conventional PT plus functional strength trainingBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Obvious unilateral visuospatial neglect
  • Upper limb movement deficits attributable to non-stroke pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's Hospital NHS Trust

London, SW17 0RE, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Valerie M Pomeroy, PhD

    St George's, University of London

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2006

First Posted

August 7, 2006

Study Start

June 1, 2005

Study Completion

December 1, 2006

Last Updated

June 8, 2015

Record last verified: 2006-08

Locations

GB(1)