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

Chang Gung Medical Foundation

Status: Completed

Conditions: Stroke

Treatments: Behavioral: home-based MTOT; Behavioral: hospital-based therapy; Behavioral: hospital-based MTOT

Study type: Interventional

Funder types: Other

Identifiers

NCT02432755

103-7164A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 3 patient groups

home-based MTOT

Experimental group

Description:

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

Treatment:

Behavioral: home-based MTOT

hospital-based therapy

Active Comparator group

Description:

hospital-based individualized occupational therapy

Treatment:

Behavioral: hospital-based therapy

hospital-based MTOT

Experimental group

Description:

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

Treatment:

Behavioral: hospital-based MTOT