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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432755
• Other study ID #: 103-7164A3
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: February 5, 2017
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Taipei Chang Gung Memorial Hospital	Taipei
Taiwan	Taoyuan Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	World Health Organization Quality of Life (WHOQOL)-BREF	for caregiver evaluation	baseline, 4 weeks
Other	satisfaction questionnaire		baseline, 4 weeks
Other	patient-reported fatigue and pain ratings		baseline, 4 weeks
Primary	Change scores of Fugl-Meyer Assessment (FMA)		baseline, 4 weeks, 3 months
Primary	Change scores of Modified Rankin Scale (mRS)		baseline, 4 weeks, 3 months
Secondary	Change scores of Box and Block Test (BBT)		baseline, 4 weeks, 3 months
Secondary	Change scores of grip and pinch power		baseline, 4 weeks, 3 months
Secondary	Change scores of Revised Nottingham Sensory Assessment (RNSA)		baseline, 4 weeks, 3 months
Secondary	Change scores of Barthel Index (BI)		baseline, 4 weeks, 3 months
Secondary	Change scores of Activity monitors (ActiGraph)		baseline, 4 weeks, 3 months
Secondary	Change scores of Stroke Impact Scale (SIS) Version 3.0		baseline, 4 weeks, 3 months
Secondary	Change scores of Motor Activities Log (MAL)		baseline, 4 weeks, 3 months
Secondary	Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)		baseline, 4 weeks, 3 months