Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation

Buddhist Tzu Chi Medical Foundation

Status: Enrolling

Conditions: Stroke Rehabilitation

Treatments: Other: kinetic exergaming; Other: robotic practice; Other: conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05492175

10-M-161

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups

proximal-prioritized robotic practice plus kinetic exergaming group

Experimental group

Description:

60 minutes per day, 3 days per week for 6 weeks

Treatment:

Other: robotic practice

Other: kinetic exergaming

distal-prioritized robotic practice plus kinetic exergaming group

Active Comparator group

Description:

60 minutes per day, 3 days per week for 6 weeks

Treatment:

Other: robotic practice

Other: kinetic exergaming

robotic practice plus conventional therapy group

Active Comparator group

Description:

60 minutes per day, 3 days per week for 6 weeks

Treatment:

Other: conventional therapy

Other: robotic practice