NCT00322192

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
300

participants targeted

Target at P75+ for phase_2 stroke

Timeline
Completed

Started Jan 2004

Typical duration for phase_2 stroke

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 10, 2015

Status Verified

May 1, 2006

First QC Date

May 4, 2006

Last Update Submit

June 8, 2015

Conditions

Keywords

Stroke rehabilitationPhysical Therapy

Outcome Measures

Primary Outcomes (2)

  • Maximum torque around the knee joint

  • gait velocity

Secondary Outcomes (7)

  • Modified Rivermead Mobility Index

  • Lower limb kinematics during standing up

  • Lower limb kinematics during sitting down

  • Lower limb kinematics during walking

  • timing and pattern of muscle activation during functional activity

  • +2 more secondary outcomes

Interventions

Eligibility Criteria

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

You may qualify if:

  • Subjects in this study will:
  • be aged over 50 years.
  • be between one week and three months after stroke when recruited to the study;
  • have been independently mobile indoors, with or without aids, before the stroke;
  • have some voluntary movement in the paretic lower limb i.e. score above 28/100 on the lower limb section of the Motricity Index43;
  • demonstrate adequate orientation and communication (be able to complete a one-stage command using the non-paretic upper limb e.g. point at the ceiling).
  • In addition those who agree to participate in TMS measurement will have no contraindications to TMS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St George's Hospital NHS Trust

London, London, SW17 0RE, United Kingdom

Location

Epsom and St Helier NHS Trust

Carshalton, Surrey, SM5 1AA, United Kingdom

Location

Ashford and St Peter's Hospitals NHS Trust

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Mayday University Hospital NHS Trust

Thornton Heath, Surrey, CR7 7YE, United Kingdom

Location

Related Publications (1)

  • Kerr A, Clark A, Cooke EV, Rowe P, Pomeroy VM. Functional strength training and movement performance therapy produce analogous improvement in sit-to-stand early after stroke: early-phase randomised controlled trial. Physiotherapy. 2017 Sep;103(3):259-265. doi: 10.1016/j.physio.2015.12.006. Epub 2016 Feb 11.

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 London, UK

    STUDY CHAIR
  • Emma V Cooke, MSc

    St George's University London, UK

    PRINCIPAL INVESTIGATOR
  • Raymond C Tallis, FMedSci

    University of Manchester

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2006

First Posted

May 5, 2006

Study Start

January 1, 2004

Study Completion

December 1, 2006

Last Updated

June 10, 2015

Record last verified: 2006-05

Locations