Clinical trial NCT02432755: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: home-based rehabilitation
stroke
combination therapy
client-centered approach
post-acute
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Change scores of Fugl-Meyer Assessment (FMA)
timeFrame: baseline, 4 weeks, 3 months
measure: Change scores of Modified Rankin Scale (mRS)
timeFrame: baseline, 4 weeks, 3 months
Secondary outcomes:
measure: Change scores of Box and Block Test (BBT)
timeFrame: baseline, 4 weeks, 3 months
measure: Change scores of grip and pinch power
timeFrame: baseline, 4 weeks, 3 months
measure: Change scores of Revised Nottingham Sensory Assessment (RNSA)
timeFrame: baseline, 4 weeks, 3 months
measure: Change scores of Barthel Index (BI)
timeFrame: baseline, 4 weeks, 3 months
measure: Change scores of Activity monitors (ActiGraph)
timeFrame: baseline, 4 weeks, 3 months
measure: Change scores of Stroke Impact Scale (SIS) Version 3.0
timeFrame: baseline, 4 weeks, 3 months
measure: Change scores of Motor Activities Log (MAL)
timeFrame: baseline, 4 weeks, 3 months
measure: Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: baseline, 4 weeks, 3 months
Other outcomes:
measure: World Health Organization Quality of Life (WHOQOL)-BREF
timeFrame: baseline, 4 weeks
measure: satisfaction questionnaire
timeFrame: baseline, 4 weeks
measure: patient-reported fatigue and pain ratings
timeFrame: baseline, 4 weeks
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
Study officials:
References: