NCT01693341

Brief Summary

To examine the feasibility of improving stroke patients' physical functional recovery and social participation through improving caregiver's care capability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

September 20, 2012

Last Update Submit

July 30, 2024

Conditions

Stroke

Keywords

Chronic stroke patientsStroke rehabilitationCaregiverCaregiver-mediated intervention

Outcome Measures

Primary Outcomes (1)

  • Stroke Impact Scale

    Change from baseline in Stroke Impact Scale at 12 weeks

    Baseline and 12 weeks

Secondary Outcomes (6)

  • 10-meter walking speed

    Baseline and 12 weeks

  • Berg balance scale

    Baseline and 12 weeks

  • 6-min walking distance

    Baseline and 12 weeks

  • Bathel index score

    Baseline and 12 weeks

  • Lawton Instrumental Activities of Daily Living scale (IADL)

    Baseline and 12 weeks

  • +1 more secondary outcomes

Other Outcomes (2)

  • Center for Epidemiologic Studies Depression Scale

    Baseline and 12 weeks

  • Caregiver Burden Scale

    baseline and 12 weeks

Study Arms (2)

Care-giver mediated training

ACTIVE COMPARATOR

Each patient and the caregiver of the intervention group received weekly home training and exercise counseling by a physical therapist about the caregiver mediated home exercise skill for stroke patient. The training program were progress weekly based on the patient's need.

Other: Care-giver mediated training

Standard-care

NO INTERVENTION

Maintain the inherent standard-care

Interventions

Care-giver mediated trainingOTHER

A physical therapist visited each subject and the caregiver (of the intervention group) once weekly for about 90 min/session to teach patient-skills and caregiver-skills. The therapist first reviewed the condition of each patient and planned patient-specific training programs, continuously performed 12 weeks.

Care-giver mediated training

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V)
  • No longer undertaking active rehabilitation program(defined as ≤2 times/wk rehabilitation activities)

You may not qualify if:

  • Recurring strokes
  • Mental or cognitive impairment
  • Severe orthopedic disability or unstable medical conditions (such as severe rheumatoid arthritis or acute myocardial infarction)
  • Caregiver with mental/behavioral disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph Hospital

Kaohsiung City, 80288, Taiwan

Location

Related Publications (1)

  • Galvin R, Cusack T, O'Grady E, Murphy TB, Stokes E. Family-mediated exercise intervention (FAME): evaluation of a novel form of exercise delivery after stroke. Stroke. 2011 Mar;42(3):681-6. doi: 10.1161/STROKEAHA.110.594689. Epub 2011 Jan 13.

    PMID: 21233462BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Alan. C Tsai, PhD

    Asia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 26, 2012

Study Start

October 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

TW(1)