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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02779036 |
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Date of registration:
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15/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Optimizing Walking Function of Stroke Survivors by a Task-Oriented Home Exercise Program
TOHE |
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Scientific title:
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The Effects of a Structured, Progressive, Task-oriented Home Exercise Program on Walking Competency in Individual Post Stroke |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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63 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02779036 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Myanmar
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Contacts
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Name:
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Vimonwan Hiengkaew, PhD. MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mahidol University |
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Name:
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Chutima Jalayondeja, Dr.P.H. MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mahidol University |
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Name:
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Jarugool Tretriluxana, PhD. MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mahidol University |
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Name:
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Sopa Pichaiyongwongdee, M.Sc. B.Sc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mahidol University |
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Name:
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Thin Thin Moe, M.Med.Tech |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mahidol University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Either side of both type first stroke within 2 weeks to six months of onset with
confirmatory diagnosis by CT Scan and MRI.
2. Age between 40 to 65 years old.
3. Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3)
4. Able to comprehend the instructions with good cognition measured by Mini-Mental State
Examination (MMSE > 23).
5. Postadoption stage of readiness to change measured by the Stages of Change
Questionnaire (stage 4 and 5)
Exclusion Criteria:
1. Diagnosed with other neurological disorder such as Parkinson's disease, peripheral
nerve injury.
2. 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)
3. Fugl Meyer Assessment score (lower extremity) less than = 21
4. Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer
(ROM) =1 in each joint).
5. Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) =
1 in hip, knee and ankle joint movement).
Age minimum:
40 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Procedure: Task-oriented home exercise
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Procedure: Usual Physiotherapy Care
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Primary Outcome(s)
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6 Minutes Walk Test
[Time Frame: up to 8 weeks]
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10 Meter Walk Test
[Time Frame: up to 8 weeks]
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Secondary Outcome(s)
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Berg Balance Scale
[Time Frame: up to 8 weeks]
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Dynamic Gait Index
[Time Frame: Baseline and 8 weeks]
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Stroke Impact Scale (Participation)
[Time Frame: Baseline and 8 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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