Clinical trial NCT04260061: Differential Effectiveness of Robotic Assisted Therapy on Upper Extremity Function in Patients With Chronic Stroke
Official title: Differential Effectiveness of Robotic Assisted Therapy on Upper Extremity Function and Health Related Outcomes in Patients With Chronic Stroke: a Comparison of Exoskeleton vs. End Effector Training Systems
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Stroke
Keywords: robotic-assisted therapy
Rehabilitation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to: determine the effects of exoskeleton vs. end effector training systems on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in patients with chronic stroke.

Detailed description: According to the theory and literature review, there are two hypotheses in this study. One is that exoskeleton training system has better benefits than end-effector training system in motion control techniques, joint mobility and muscle tone control. Second, end-effector training system has better benefits than exoskeleton training system in the functional activity level and daily life participation.

Eligibility criteria: Inclusion Criteria:

* Chronic Stroke more than 3 months.
* FMA score 29\~59.
* Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
* Mini Mental State Examination ≥ 24 and no serious cognitive impairment.
* Learn more about the research content and can provide informed consent.

Exclusion Criteria:

* Other neurological disease
* Inability to understand instructions
* current participation in any other research
* Botulinum Toxin injection within 3 months

Primary outcomes:
measure: Change scores of Mini-Mental State Exam (MMSE)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Fugl-Myer Assessment (FMA)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Active Range of Motion (AROM)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Modified Ashworth Scale (MAS)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of grip and pinch power
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Medical Research Council scale (MRC)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Revised Nottingham Sensory Assessment (rNSA)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: MyotonPRO
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Wolf Motor Function Test (WMFT)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Box and Block Test (BBT)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Motor Activity Log (MAL)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Stroke Impact Scale (SIS)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of stroke self-efficacy questionnaire (SSEQ)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Daily Living Self-Efficacy Scale (DLSES)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
measure: Change scores of Functional Abilities Confidence Scale (FACS)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: