NCT00666744

Brief Summary

The aim of the study is to evaluate the functional recovery in two groups of primary stroke patients presenting with moderate/severe disability over a six month period through the implementation of a randomised controlled trial. The first group or the experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The second group or the control group will receive routine therapy with no additional formal input from their family members. A secondary aim of the project is to evaluate the impact of the FAME programme on the person with stroke and the individual (s) assisting in the delivery of exercises.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

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

April 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 29, 2008

Status Verified

April 1, 2008

Enrollment Period

11 months

First QC Date

April 23, 2008

Last Update Submit

October 28, 2008

Conditions

WeaknessBalance

Keywords

exercisefrequencyduration

Outcome Measures

Primary Outcomes (1)

  • Fugl Meyer (FM) Assessment

    Baseline, post intervention and 3 month follow-up

Secondary Outcomes (6)

  • Berg Balance Scale (BBS)

    Baseline, post intervention and 3 month follow-up

  • Motor Assessment Scale (MAS)

    Baseline, post-intervention and 3 month follow up

  • Six Minute Walk Test (SMWT)

    Baseline, post-intervention and 3 month follow up

  • Barthel Index (BI)

    Baseline, post-intervention and 3 month follow up

  • Re-integration into Normal Living Index (RNLI)

    Baseline, post-intervention and 3 month follow up

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Exercise Intervention - additional lower limb exercises will be completed by the person with stroke with the assistance of his/her family for 35 minutes daily for a period of 8 weeks.

Other: Family Mediated Exercise Therapy

2

NO INTERVENTION

Participants in this group will receive routine exercise therapy following stroke

Interventions

Family Mediated Exercise TherapyOTHER

35 minutes of lower limb exercises to be completed by the person with stroke on a daily basis with the assistance of their family for a period of 8 weeks.

1

Eligibility Criteria

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

You may qualify if:

  • diagnosis of first unilateral stroke
  • Patients who score between 3.2 and 5.2 on the Orpington Prognostic Scale
  • Patients participating in a physiotherapy programme
  • Patients willing to give informed written consent
  • Patients with family willing to participate in their assigned physiotherapy intervention programme

You may not qualify if:

  • hemiplegia of a non-vascular origin
  • discharged from hospital less than two weeks following stroke
  • pre-existing neurological disorder
  • any lower limb orthopaedic condition that may limit exercise capacity
  • aphasia
  • cognitive impairment
  • not willing to give written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beaumont Hospital

Dublin, Ireland

RECRUITING

MaterMisercordiae University Hospital

Dublin, Ireland

RECRUITING

Related Publications (1)

  • Galvin R, Cusack T, Stokes E. A randomised controlled trial evaluating family mediated exercise (FAME) therapy following stroke. BMC Neurol. 2008 Jun 20;8:22. doi: 10.1186/1471-2377-8-22.

    PMID: 18570643DERIVED

MeSH Terms

Conditions

AstheniaMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Emma Stokes, PhD

    University of Dublin, Trinity College

    PRINCIPAL INVESTIGATOR

  • Tara Cusack, PhD

    University College Dublin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma K Stokes, PhD

CONTACT

00 353 1 896 2127estokes@tcd.ie

Rose Galvin, BSc

CONTACT

00 353 1 896 3613rgalvin@tcd.ie

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

April 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 29, 2008

Record last verified: 2008-04

Locations

IE(2)