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

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ClinicalTrials.gov Identifier: NCT02432755
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: home-based MTOT Behavioral: hospital-based therapy Behavioral: hospital-based MTOT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432755


Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan
Taipei Chang Gung Memorial Hospital
Taipei, Taiwan
Taoyuan Chang Gung Memorial Hospital
Taoyuan, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02432755     History of Changes
Other Study ID Numbers: 103-7164A3
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: November 2016
Keywords provided by Chang Gung Memorial Hospital:
home-based rehabilitation
stroke
combination therapy
client-centered approach
post-acute
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases