Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke
1 other identifier
interventional
3
1 country
3
Brief Summary
The specific aims of this study will be:
- 1.To compare the immediate and retention treatment effects of the patients receiving home-based mirror therapy combined with task-oriented training (MTOT) with a hospital-based MTOT group and a hospital conventional rehabilitation group on different aspects of outcomes.
- 2.To examine the feasibility, satisfaction, and safety of this novel home-based MTOT program.
- 3.To investigate the factors that may affect the efficacy of home-based stroke rehabilitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Mar 2016
Shorter than P25 for not_applicable stroke
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFebruary 7, 2017
November 1, 2016
8 months
April 29, 2015
February 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change scores of Fugl-Meyer Assessment (FMA)
baseline, 4 weeks, 3 months
Change scores of Modified Rankin Scale (mRS)
baseline, 4 weeks, 3 months
Secondary Outcomes (8)
Change scores of Box and Block Test (BBT)
baseline, 4 weeks, 3 months
Change scores of grip and pinch power
baseline, 4 weeks, 3 months
Change scores of Revised Nottingham Sensory Assessment (RNSA)
baseline, 4 weeks, 3 months
Change scores of Barthel Index (BI)
baseline, 4 weeks, 3 months
Change scores of Activity monitors (ActiGraph)
baseline, 4 weeks, 3 months
- +3 more secondary outcomes
Other Outcomes (3)
World Health Organization Quality of Life (WHOQOL)-BREF
baseline, 4 weeks
satisfaction questionnaire
baseline, 4 weeks
patient-reported fatigue and pain ratings
baseline, 4 weeks
Study Arms (3)
home-based MTOT
EXPERIMENTALHome-based mirror therapy combined with task-oriented training (MTOT)
hospital-based therapy
ACTIVE COMPARATORhospital-based individualized occupational therapy
hospital-based MTOT
EXPERIMENTALhospital-based mirror therapy combined with task-oriented training (MTOT)
Interventions
The home-based MTOT group will receive 30 minutes of MT followed by 30 minutes of TOT per session. The intervention will take place in the participant's home environment. During the mirror practices, the patient will seat close to a table which the mirror box will be placed at the mid-sagittal plane. During MT, the participant will be encouraged to actively move their paretic arm and hand concurrently with the mirror reflection of the movement of the nonparetic arm and hand as possible as they can. If necessary, the therapist will assist the participant in moving the paretic hand to synchronize the movement with the nonparetic hand.
The control group will receive a dose-matched, individualized occupational therapy at a hospital. The participants will receive customary rehabilitation programs as usual performed at hospitals for 1 hour per session. The treatment protocol will include: (a) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques, (b) fine motor or dexterity training, (c) arm exercises or gross motor training, (d) muscle strengthening of the affected upper limb, and (e) activities of daily living training or functional task practice.
The hospital-based MTOT group will also receive 30 minutes of MT followed by 30 minutes of TOT per session at a hospital. The intervention will take place in the occupational therapy clinic. The treatment modalities in the hospital will be selected and provided for this group. Most of the treatment principles and components are the same as aforementioned in the home-based MTOT. However, the major differences between home-based and hospital-based MTOT are the treatment contexts, environments and functional modalities used.
Eligibility Criteria
You may qualify if:
- diagnosed as having a unilateral stroke
- at least 3 months after stroke onset
- from 20 to 80 years of age
- having completed acute rehabilitation care or discharged home
- a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
- able to follow the therapy instructions (cognition status will be measured by the Montreal Cognitive Assessment)
- capable of participating in therapy and assessment sessions.
You may not qualify if:
- neglect
- global or receptive aphasia
- major medical problems
- comorbidities that influenced UE usage or caused severe pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Taipei Chang Gung Memorial Hospital
Taipei, Taiwan
Taoyuan Chang Gung Memorial Hospital
Taoyuan District, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2015
First Posted
May 4, 2015
Study Start
March 1, 2016
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
February 7, 2017
Record last verified: 2016-11