NCT02779036

Brief Summary

In a randomized-controlled study, the effects of a structured, progressive, task-oriented home exercise program to optimize walking competency will be evaluated in subacute stroke survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

May 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 8, 2017

Status Verified

October 1, 2016

Enrollment Period

10 months

First QC Date

May 15, 2016

Last Update Submit

June 7, 2017

Conditions

Stroke

Keywords

Stroketask-oriented home exercisewalking competencyUsual Physiotherapy care

Outcome Measures

Primary Outcomes (2)

  • 6 Minutes Walk Test

    Patients will be measured their walking distance by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing.

    up to 8 weeks

  • 10 Meter Walk Test

    Patients will be measured their walking speed by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing.

    up to 8 weeks

Secondary Outcomes (3)

  • Berg Balance Scale

    up to 8 weeks

  • Dynamic Gait Index

    Baseline and 8 weeks

  • Stroke Impact Scale (Participation)

    Baseline and 8 weeks

Study Arms (2)

Task-oriented Exercise

EXPERIMENTAL

Structured, progressive, task-oriented, home exercise program

Procedure: Task-oriented home exercise

Usual Care

ACTIVE COMPARATOR

Usual Physiotherapy Care

Procedure: Usual Physiotherapy Care

Interventions

Task-oriented home exercisePROCEDURE

Structured, walking related task-oriented home exercise program with three progressive steps, at moderate to high intensity, 60 minutes per session, three sessions per week for total 8 weeks.

Task-oriented Exercise
Usual Physiotherapy CarePROCEDURE

Deficits-oriented free active and resisted lower extremity exercises with bicycling and overground walking , 60 minutes per session, three sessions per week for total 8 weeks.

Usual Care

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Either side of both type first stroke within 2 weeks to six months of onset with confirmatory diagnosis by CT Scan and MRI.
  • Age between 40 to 65 years old.
  • Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3)
  • Able to comprehend the instructions with good cognition measured by Mini-Mental State Examination (MMSE \> 23).
  • Postadoption stage of readiness to change measured by the Stages of Change Questionnaire (stage 4 and 5)

You may not qualify if:

  • Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury.
  • Serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg)
  • Fugl Meyer Assessment score (lower extremity) less than ≤ 21
  • Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint).
  • Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Rehabilitation Hospital

Yangon, Burma

Location

Physical Medicine and Rehabilitation Department, Yangon General Hospital

Yangon, Burma

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Thin Thin Moe, M.Med.Tech

    Mahidol University

    PRINCIPAL INVESTIGATOR

  • Chutima Jalayondeja, Dr.P.H. MSc

    Mahidol University

    STUDY CHAIR

  • Sopa Pichaiyongwongdee, M.Sc. B.Sc

    Mahidol University

    STUDY DIRECTOR

  • Vimonwan Hiengkaew, PhD. MSc

    Mahidol University

    STUDY DIRECTOR

  • Jarugool Tretriluxana, PhD. MSc

    Mahidol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph D candidate

Study Record Dates

First Submitted

May 15, 2016

First Posted

May 20, 2016

Study Start

June 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 8, 2017

Record last verified: 2016-10

Locations

BU(2)