Effects of Robot-Assisted Combined Therapy in Upper Limb Rehabilitation in Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

The main purpose of this study is to examine the treatment effects and the combined-therapy of the robot-assisted therapy (RAT) by using two groups of combined-therapy with different sensory feedback and one group of unilateral RAT in the investigators trial to compare the relative treatment effects to mirror therapy group, bilateral RAT, and conventional rehabilitation (CR) considering motor ability, basic daily functions, mobility, quality of life, and kinematic variables.

Detailed Description

Stroke remains a leading cause of permanent disability in Taiwan and many other countries. The high incidence of stroke and the decreased mortality from stroke which imply the urgent needs for effective rehabilitation. Various contemporary rehabilitation interventions focused on restoring upper limb motor function have been advocated for stroke rehabilitation. Robot-assisted therapy (RAT), one current prominent activity-based approach, has emerged that incorporates therapeutic elements for success in stroke motor rehabilitation: combined with neuromuscular electrical stimulation and mirror therapy into its design. However, scientific evidence for the effects of the RAT and its combined-therapy on functional outcomes (e.g., motor and daily functions) in stroke patients remains limited. Furthermore, there is a need to identify the proper protocol and intervention type. This research project will use randomized controlled trial design to address these issues.
The main purpose of this study is to examine the treatment effects and the combined-therapy of the RAT by using two groups of combined-therapy with different sensory feedback and one group of unilateral RAT in our trail to compare the relative treatment effects to mirror therapy group, bilateral RAT, and conventional rehabilitation (CR) considering motor ability, basic daily functions, mobility, quality of life, and kinematic variables.
The inclusion criteria of subjects are first-ever unilateral stroke with more than 3 months onset ; (2) an initial UL subsection of the Fugl-Meyer Assessment score of 18 to 56 indicating moderate to severe and moderate UL movement impairment; (3) no excessive spasticity in any of the joints of the affected UL (shoulder, elbow, wrist, fingers); (4) be able to follow study instructions and perform study tasks; (5) without upper limb fracture within 3 months; (6) lack of participation in any experimental rehabilitation or drug studies during the study period; (7) welling to provide written informed consent ; and (8) able to realize and respond to oral instructions. Patients with neural or psychological medical history, recurrent stroke or attack by epilepsy during the intervention will be excluded. Expected sample size is 120.
Subjects will be randomly assigned to one of the six groups: (1) robot-assisted therapy combined with neuromuscular electrical stimulation (RAT-NMES) ; (2) robot-assisted therapy combined with mirror therapy (RAT-MT) ; (3) mirror therapy group; (4) unilateral robot-assisted therapy group ; (5) bilateral robot-assisted therapy and (6) conventional rehabilitation (CR). All subjects in the study will receive treatment from registered occupational therapist 1.5 hours each day, five days a week for four weeks. Pretest and posttest will be hold before and after the intervention to check if the subjects had any improvement. The outcome measures are kinematic analysis of the upper and lower limb movement variables, the Fugl-Meyer Assessment (FMA), Medical Research Council scale (MRC), MYOTON-3, accelerometers, Functional Ambulation Category (FAC), Ten-meter walk test, Functional Independence Measure (FIM), Stroke Impact Scale (SIS), Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), ABILHAND, Motor Activity Log (MAL), and Modified Ashworth Scale (MAS). All the data will be calculated by SPSS 13.0. Subject's age, sex, time after stroke in each group will be compared by descriptive statistics. The change of outcome measures after intervention in each group will be calculated by ANOVA to see if combined therapy had better effectiveness than the other groups.

Conditions

Interventions

  • Conventional rehabilitation Other
    Intervention Desc: Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RAT and MT groups.
    ARM 1: Kind: Experimental
    Label: Conventional rehabilitation
    Description: Conventional rehabilitation provided by therapist.
  • Mirror therapy Device
    Intervention Desc: This protocol includes mirror therapy and functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.
    ARM 1: Kind: Experimental
    Label: Mirror therapy
    Description: Patients practice motion in a mirror box, and look into mirror while practicing.
  • RAT-NMES Behavioral
    Other Names: RAT combined neuromuscular electrical stimulation; RAT-neuromuscular electrical stimulation
    Intervention Desc: This combined RAT- treatment involves the same protocol as the RAT regimen except that patients receive neuromuscular electrical stimulation (NMES) concurrently with RAT.
    ARM 1: Kind: Experimental
    Label: RAT-NMES
    Description: The combined treatment of robot-assisted therapy and neuromuscular electrical stimulation.
  • RAT-MT Behavioral
    Other Names: RAT combined MT; RAT-mirror therapy
    Intervention Desc: This combined RAT- treatment involves the same protocol as the RAT regimen except that patients receive mirror therapy instead of functional activities training after RAT.
    ARM 1: Kind: Experimental
    Label: RAT-MT
    Description: The combined treatment of robot-assisted therapy and mirror therapy.
  • Unilateral RAT Behavioral
    Other Names: URAT
    Intervention Desc: This protocol includes warm-up, unilateral RAT, and functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The unilateral RAT session uses the robot-assisted arm trainer, InMotion Isokinetic Testing and Evaluation System.
    ARM 1: Kind: Experimental
    Label: Unilateral RAT
    Description: Unilateral robot-assisted therapy provided by InMotion Isokinetic Testing and Evaluation System.
  • Bilateral RAT Behavioral
    Other Names: BRAT
    Intervention Desc: This protocol includes warm-up, bilateral RAT, and functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The unilateral RAT session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
    ARM 1: Kind: Experimental
    Label: Bilateral RAT
    Description: Bilateral robot-assisted therapy provided by Bi-Manu-Track.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary change of kinematic analyses within three days before and immediately after the intervention No
Primary change of Fugl-Meyer Assessment within three days before and immediately after the intervention No
Secondary change of 10-Meter Walk Test (10MWT) within three days before and immediately after the intervention No
Secondary change of Wolf Motor Function Test within three days before and immediately after the intervention No
Secondary change of Functional Independence Measure within three days before and immediately after the intervention No
Secondary change of The Action Research Arm Test within three days before and immediately after the intervention No

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