Clinical trial NCT05492175: Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation
Official title: Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Rehabilitation
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 72
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: This research program aims at investigating the effects of upper-limb robotic therapy primed with interactive exergaming as an innovative hybrid regimen in stroke rehabilitation.

Detailed description: Robotic therapy can potentially be a movement-based priming technique to promote rebalancing of cortical excitability and create an enriched neuroplastic environment by priming the brain to facilitate motor and functional recovery. The proximal priority and distal priority robotic priming techniques may bring differential effects. This proposed research project aims to: (1) examine the effects of proximal priority versus distal priority of bilateral robotic priming combined with exergaming on sensorimotor function, daily function, self-efficacy, quality of life, and motor control strategy in patients with stroke, (2) investigate the 3-month retention effects of the three approaches, and (3) identify the potential predictors of functionally relevant changes after therapy.

Eligibility criteria: Inclusion Criteria:

1. a first ever-stroke≧3 months
2. age range between 20 to 80 years
3. baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56
4. no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale \< 3 at any joints)
5. able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22)
6. can maintain a step-standing position for at least 30 seconds
7. can walk for at least 10 meters with or without device
8. no participation in further experimental rehabilitation or drug studies during the duration of the project

Exclusion Criteria:

1. acute inflammation and pain
2. concomitant neurologic, neuromuscular or orthopedic conditions that may impede participation in this research.

Primary outcomes:
measure: Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks and 18 weeks
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Change from Baseline 10 meter walk test (10-MWT) at 6 weeks and 18 weeks
timeFrame: Baseline, 6 weeks, and 18 weeks
Secondary outcomes:
measure: Medical Research Council scale (MRC)
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA)
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Functional Independence Measure (FIM)
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Stroke Self-Efficacy Questionnaire (SSEQ)
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Adverse events (pain and fatigue)
timeFrame: through study completion, an average of 18 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Feng Yuan Hospital, Ministry of Health and Welfare
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wan Fang Hospital
city: Taipei
country: Taiwan
facility: Taipei Tzu Chi Hospital
Study officials:
affiliation: National Taiwan University
name: Keh-Chung Lin, Sc.D
role: PRINCIPAL_INVESTIGATOR
References: