Clinical trial NCT03917511: Effects of Combined Robot-assisted Therapy With Mirror Priming in Stroke Patients
Official title: Effects of Combined Robot-assisted Therapy With Mirror Priming on Hand Function and Health-related Conditions in Patients With Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Keywords: Stroke
Mirror therapy
Robotic Training
Neurorehabilitation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of combining robotic-assisted training and mirror therapy on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in stroke patients.

Detailed description: Based on trigger theory, this study designed a combining robotic-assisted training and mirror therapy. Before robotic-assisted training, a mirror therapy is performed to double the healing effect of robotic-assisted training.

This study hypothesized that combining robotic-assisted training and mirror therapy can improve the performance of hand function in stroke patients and promote daily life function, quality of life, and self-efficacy compared to single machine-assisted therapy.

Eligibility criteria: Inclusion Criteria:

1. Brain injury more than 3 months.
2. Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
3. The myoelectric signal can be detected to activate the instrument
4. unilateral paresis (FMA score\<60)
5. no serious cognitive impairment (i.e., Mini Mental State Exam score \> 24)
6. can provide informed consent

Exclusion Criteria:

1. Other neurological disease
2. Complete sense of body defect
3. Inability to understand instructions
4. current participation in any other research
5. Botulinum Toxin injection within 3 months

Primary outcomes:
measure: Change scores of Fugl-Myer Assessment (FMA)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Active Range of Motion (AROM)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of grip and pinch power(Jamar hand dynamometer)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of MyotonPro
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Modified Ashworth Scale (MAS)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Medical Research Council scale (MRC)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of pressure pain threshold
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Revised Nottingham Sensory Assessment (RNSA)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Wolf Motor Function Test (WMFT)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Jamar hand dynamometer
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Mini-Mental State Exam (MMSE)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Motor Activity Log (MAL)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Stroke Impact Scale (SIS)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of stroke self-efficacy questionnaire (SSEQ)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Daily Living Self-Efficacy Scale (DLSES)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Functional Abilities Confidence Scale (FACS)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Secondary outcomes:
measure: Kinematic Analysis
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline)
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: