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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02432755

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patient Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: home-based MTOT Behavioral: hospital-based therapy Behavioral: hospital-based MTOT	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke: a Randomized Controlled Trial

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: home-based MTOT Home-based mirror therapy combined with task-oriented training (MTOT)	Behavioral: home-based MTOT 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.
Active Comparator: hospital-based therapy hospital-based individualized occupational therapy	Behavioral: hospital-based therapy 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.
Experimental: hospital-based MTOT hospital-based mirror therapy combined with task-oriented training (MTOT)	Behavioral: hospital-based MTOT 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.

Arm

Intervention/Treatment

Experimental: home-based MTOT

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

Behavioral: home-based MTOT

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.

Active Comparator: hospital-based therapy

hospital-based individualized occupational therapy

Behavioral: hospital-based therapy

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.

Experimental: hospital-based MTOT

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

Behavioral: hospital-based MTOT

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Change scores of Stroke Impact Scale (SIS) Version 3.0 [baseline, 4 weeks, 3 months]
Change scores of Motor Activities Log (MAL) [baseline, 4 weeks, 3 months]
Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL) [baseline, 4 weeks, 3 months]

Other Outcome Measures

World Health Organization Quality of Life (WHOQOL)-BREF [baseline, 4 weeks]
for caregiver evaluation
satisfaction questionnaire [baseline, 4 weeks]
patient-reported fatigue and pain ratings [baseline, 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung	Taiwan
2	Taipei Chang Gung Memorial Hospital	Taipei	Taiwan
3	Taoyuan Chang Gung Memorial Hospital	Taoyuan	Taiwan