Skip to main content
OpenTrials
Completed

NCT Number: NCT02432755

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

home-based MTOT

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. Change scores of Fugl-Meyer Assessment (FMA)

    Time frame: baseline, 4 weeks, 3 months

  2. Change scores of Modified Rankin Scale (mRS)

    Time frame: baseline, 4 weeks, 3 months

Secondary outcomes

  1. Change scores of Box and Block Test (BBT)

    Time frame: baseline, 4 weeks, 3 months

  2. Change scores of grip and pinch power

    Time frame: baseline, 4 weeks, 3 months

  3. Change scores of Revised Nottingham Sensory Assessment (RNSA)

    Time frame: baseline, 4 weeks, 3 months

  4. Change scores of Barthel Index (BI)

    Time frame: baseline, 4 weeks, 3 months

  5. Change scores of Activity monitors (ActiGraph)

    Time frame: baseline, 4 weeks, 3 months

  6. Change scores of Stroke Impact Scale (SIS) Version 3.0

    Time frame: baseline, 4 weeks, 3 months

  7. Change scores of Motor Activities Log (MAL)

    Time frame: baseline, 4 weeks, 3 months

  8. Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)

    Time frame: baseline, 4 weeks, 3 months

Other outcomes

  1. World Health Organization Quality of Life (WHOQOL)-BREF

    Time frame: baseline, 4 weeks

    for caregiver evaluation

  2. satisfaction questionnaire

    Time frame: baseline, 4 weeks

  3. patient-reported fatigue and pain ratings

    Time frame: baseline, 4 weeks

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 4, 2015
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.