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Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
home-based MTOT
hospital-based therapy
hospital-based MTOT
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring home-based rehabilitation, stroke, combination therapy, client-centered approach, post-acute

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • neglect
  • global or receptive aphasia
  • major medical problems
  • comorbidities that influenced UE usage or caused severe pain

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital
  • Taipei Chang Gung Memorial Hospital
  • Taoyuan Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

home-based MTOT

hospital-based therapy

hospital-based MTOT

Arm Description

Home-based mirror therapy combined with task-oriented training (MTOT)

hospital-based individualized occupational therapy

hospital-based mirror therapy combined with task-oriented training (MTOT)

Outcomes

Primary Outcome Measures

Change scores of Fugl-Meyer Assessment (FMA)
Change scores of Modified Rankin Scale (mRS)

Secondary Outcome Measures

Change scores of Box and Block Test (BBT)
Change scores of grip and pinch power
Change scores of Revised Nottingham Sensory Assessment (RNSA)
Change scores of Barthel Index (BI)
Change scores of Activity monitors (ActiGraph)
Change scores of Stroke Impact Scale (SIS) Version 3.0
Change scores of Motor Activities Log (MAL)
Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)

Full Information

First Posted
April 29, 2015
Last Updated
February 5, 2017
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02432755
Brief Title
Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke
Official Title
Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The specific aims of this study will be: 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. To examine the feasibility, satisfaction, and safety of this novel home-based MTOT program. To investigate the factors that may affect the efficacy of home-based stroke rehabilitation.
Detailed Description
In this 3-year study project, we will design a single-blind randomized controlled trial (1) to compare the treatment effects of home-based MTOT with a hospital-based MTOT group and a hospital conventional rehabilitation group, (2) to investigate the feasibility, satisfaction, and safety of this home-based program, and (3) to identify the factors that might influence treatment outcomes. An estimated total of 90 patients with stroke will be recruited in this study. All participants will be randomly assigned to receive home-based MTOT or hospital-based rehabilitation for a 4-week training period (a total of 12 sessions). Before the first treatment session, a client-centered questionnaire will be administered to each patient for identifying individual needs and goals. Feasibility evaluation and caregiver's wellbeing will be also assessed. Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
home-based rehabilitation, stroke, combination therapy, client-centered approach, post-acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
home-based MTOT
Arm Type
Experimental
Arm Description
Home-based mirror therapy combined with task-oriented training (MTOT)
Arm Title
hospital-based therapy
Arm Type
Active Comparator
Arm Description
hospital-based individualized occupational therapy
Arm Title
hospital-based MTOT
Arm Type
Experimental
Arm Description
hospital-based mirror therapy combined with task-oriented training (MTOT)
Intervention Type
Behavioral
Intervention Name(s)
home-based MTOT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
hospital-based therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
hospital-based MTOT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change scores of Fugl-Meyer Assessment (FMA)
Time Frame
baseline, 4 weeks, 3 months
Title
Change scores of Modified Rankin Scale (mRS)
Time Frame
baseline, 4 weeks, 3 months
Secondary Outcome Measure Information:
Title
Change scores of Box and Block Test (BBT)
Time Frame
baseline, 4 weeks, 3 months
Title
Change scores of grip and pinch power
Time Frame
baseline, 4 weeks, 3 months
Title
Change scores of Revised Nottingham Sensory Assessment (RNSA)
Time Frame
baseline, 4 weeks, 3 months
Title
Change scores of Barthel Index (BI)
Time Frame
baseline, 4 weeks, 3 months
Title
Change scores of Activity monitors (ActiGraph)
Time Frame
baseline, 4 weeks, 3 months
Title
Change scores of Stroke Impact Scale (SIS) Version 3.0
Time Frame
baseline, 4 weeks, 3 months
Title
Change scores of Motor Activities Log (MAL)
Time Frame
baseline, 4 weeks, 3 months
Title
Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
Time Frame
baseline, 4 weeks, 3 months
Other Pre-specified Outcome Measures:
Title
World Health Organization Quality of Life (WHOQOL)-BREF
Description
for caregiver evaluation
Time Frame
baseline, 4 weeks
Title
satisfaction questionnaire
Time Frame
baseline, 4 weeks
Title
patient-reported fatigue and pain ratings
Time Frame
baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: neglect global or receptive aphasia major medical problems comorbidities that influenced UE usage or caused severe pain
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Taipei Chang Gung Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
Taoyuan Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

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Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke

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