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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

a first ever-stroke≧3 months

age range between 20 to 80 years

baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56

no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale < 3 at any joints)

Disqualifiers

acute inflammation and pain

concomitant neurologic, neuromuscular or orthopedic conditions that may impede participation in this research.

Trial design

Design model

Parallel

Treatments tested in this trial

  • robotic practice

    Other intervention

    According to the group assignment, participants will start from the BMT proximal mode (i.e., forearm pronation-supination movement), and then the distal mode (i.e., wrist flexion-extension movement), and vice versa. Each participant is expected to complete approximately 400 to 600 repetitions of the proximal mode session (i.e., forearm movements) and another 400 to 600 repetitions of the distal mode session (i.e., wrist movements), respectively.

  • kinetic exergaming

    Other intervention

    All of the participants in experimental and comparison groups will practice on the exergaming for 30 minutes per session. To avoid fatigue, the four domains of programs will be provided alternately. Each program will be executed for approximately 5 minutes with warm-up, followed by a 2-minute break between programs, and cool-down. The games will be selected and adapted according to the personal capacity, the occupational role, and the rehabilitation goal of each participant. The investigators will illustrate and guide the participants to play the games and stand next to them to prevent falls from occurring. To increase security, we will place a handrail in front of the participant for support as needed.

  • conventional therapy

    Other intervention

    Participants in control group will receive 30 minutes of therapist-mediated conventional therapy per session. The training protocols of the conventional therapy will use occupational therapy techniques, such as neurodevelopmental techniques and functional task training. The therapy will be adapted to the participants' levels of motor deficits and their personal needs. The protocol will include affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques to alleviate functional deficits. The content of the functional tasks will be decided together by participants and therapists, such as picking up and putting down items in a box, lifting two soft drink bottles, and so on.

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: proximal-prioritized robotic practice plus kinetic exergaming groupExperimental treatment 2 interventions
Group B: distal-prioritized robotic practice plus kinetic exergaming groupActive comparator 2 interventions
Group C: robotic practice plus conventional therapy groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks and 18 weeks

1. The upper-extremity subscale of the FMA will be used to assess motor impairment. 2. There are 33 UE items that assess movements and reflexes of the shoulder/elbow/forearm, wrist, and hand, and coordination/speed. Each item is on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). 3. The maximum score is 66, with a subscale score of 42 for the proximal part of the arms (shoulder/elbow) and 24 for the distal part of the arm (wrist/hand/coordination) 4. The higher summed score means the greater recovery of motor impairment.

Time frame
Baseline, 6 weeks, and 18 weeks
2

Change from Baseline 10 meter walk test (10-MWT) at 6 weeks and 18 weeks

1.10 meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. 2.The total time is recorded in m/s 3.The lower total time means the greater recovery of walking speed.

Time frame
Baseline, 6 weeks, and 18 weeks

Secondary outcomes

1

Medical Research Council scale (MRC)

1. MRC measures muscle power of the affected arm and is scored on a 6-point ordinal scale (0 = no contraction, 5 = resisted to maximal strength, full power compared with the unaffected side) 2. The higher score means the greater muscle power.

Time frame
Baseline, 6 weeks, and 18 weeks
2

The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA)

1. Accelerometry is used to measure human movement. These devices record patterns of motion and non-motion. 2. All participants will be asked to wear the devices for 3 consecutive days before and after the intervention. 3. .The accelerometer will record the number of movements per minute, and the mean counts of movements per minute will be calculated. 4. The higher mean counts of movements per minute means the more activity of arm.

Time frame
Baseline, 6 weeks, and 18 weeks
3

Functional Independence Measure (FIM)

1. The FIM consists of 18 items grouped into 6 sub-scales, including self-care, sphincter control, transfer, locomotion, communication, and social cognition. 2. Each item is rated from 1 (full assistance) to 7 (full independence), according to the level of support required to perform the tasks. 3. A higher score (maximum score of 126) indicates a lower disability.

Time frame
Baseline, 6 weeks, and 18 weeks
4

Stroke Self-Efficacy Questionnaire (SSEQ)

1. The SSEQ will be used to gauge participants' confidence in their functional performance after stroke. 2. It includes 13 items and gives an overview of the factors that influence functional performance. 3. Each item will be assigned according to the perceived confidence rating on the scale of 0 (no confidence at all) to 10 (full confidence). 4. The higher summed score means the more confidence of participant.

Time frame
Baseline, 6 weeks, and 18 weeks

Other outcomes

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