Effects of RAT in Sequential Combination With CIT in Stroke Rehabilitation

National Taiwan University

Status: Unknown

Conditions: Cerebrovascular Accident

Treatments: Behavioral: RT in sequential combination with dCIT; Behavioral: Dose-matched control therapy; Behavioral: Distributed Constraint-Induced Therapy; Behavioral: Robot-Assisted Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01727648

201112104RIB

Details and patient eligibility

About

The findings of this project will contribute to the understanding of a comprehensive probe for investigation of the effects of monotherapy versus combination rehabilitation intervention after stroke, including the topics of possible underlying mechanisms of motor recovery as well as the beneficial and adverse effects of intense rehabilitation therapy, prognostic factors of the outcomes, and clinimetric properties of the instruments. The overall findings of this project will be significant in the era of knowledge translation and guide the development of innovative and effective interventions for individualized stroke rehabilitation.

Full description

The overall goal of this research project will be to provide scientific evidence of the robot-assisted therapy in sequential combination with distributed constraint-induced therapy (RT + dCIT)versus monotherapy of the robot-assisted therapy (RT), distributed constraint-induced therapy (dCIT), and a dose-matched control therapy (DMCT)in stroke rehabilitation. The specific aims of this proposed research are identified as follows:

1. The investigators will investigate the treatment effects of RT + dCIT compared to RT, CIT, and DMCT on motor ability, muscle function, sensory function, daily performance, real-world arm activity, quality of life, and motor control variables at before treatment, midterm assessment, and after treatment. In addition to study of treatment benefits, physiological responses as the potential adverse effects including post-exertional fatigue, post-exertional pain, and a biomarker of oxidative stress will be also examined in this project. The investigators hypothesized that the therapeutic regimen combining RT with dCIT will contribute to more significantly reduction in impairment and disability for stroke patients than the other intervention groups.
2. The investigators will investigate if the clinical characteristics or behavioral markers of stroke patients will influence the outcomes after interventions. The proposed potential predictors will be chronicity, side of lesion, muscle tone, motor ability of distal part of upper limb, and amount of affected hand use.
3. The investigators will examine whether the improved scores after each treatment reach clinically important changes in order to establish the clinical significance relevant for individualized medicine. The investigators will also assess and compare the clinimetric properties (e.g., validity, responsiveness, minimal detectable change, and minimal clinically important difference) of the rehabilitation outcomes to inform selection of instruments.

Enrollment: 92 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6 months onset from a first-ever unilateral stroke
• An initial UL subsection of the Fugl-Meyer Assessment score of 20 to 50 indicating moderate and moderate to severe UL movement impairment
• No balance problems sufficient to compromise safety when wearing the study's constraint device
• No excessive spasticity in any of the joints of the affected UL (modified Ashworth scale ≤ 3)
• Without upper limb fracture within 3 months
• Be able to follow study instructions and perform study tasks (Mini Mental State Examination ≥ 24)
• Willing to provide written informed consent

Exclusion criteria

• Exhibit physician-determined major medical problems or poor physical conditions that would interfere with participation
• Excessive pain in any joint that might limit participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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92 participants in 4 patient groups

RT in sequential combination with dCIT

Experimental group

Description:

The participants will received 2 weeks of RT therapy and followed by 2 weeks of distributed CIT therapy. The treatment principles of RT and distributed CIT are the same with those described in the monotherapy of RT or dCIT, respectively.

Treatment:

Behavioral: RT in sequential combination with dCIT

Distributed Constraint-Induced Therapy

Experimental group

Description:

The dCIT group will focus on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected UL in functional tasks for 1.5 hours/weekday over the 4 weeks. Participants in this group will focus on the intensive training of the affected arm in functional activities with behavioral shaping.

Treatment:

Behavioral: Distributed Constraint-Induced Therapy

Robot-Assisted Therapy

Experimental group

Description:

Participants will receive 20 training sessions (1.5 hours/day, 5 days/week for 4 consecutive weeks). The ArmeoSpring will be used in this project. It is a 5 degree-of-freedom skeleton mechanism that automates arm movement in a gravity-supported and computer-enhanced environment. The design of the arm support component of the ArmeoSpring is based on Wilmington Robotic Exoskeleton, an antigravity arm support. Instrumentation of the ArmeoSpring with position sensors at each joint enables it to be used as a 3D input device for computer game play with the hemiparetic arm. A custom software package named Vu Therapy will be also used in this project. Games were designed to simulate functional arm movements to provide training in a simple virtual reality environment.

Treatment:

Behavioral: Robot-Assisted Therapy

Dose-matched control therapy

Active Comparator group

Description:

Participants will receive 20 training sessions (1.5 hours/day, 5 days/week for 4 consecutive weeks). This group will received a structured protocol using conventional occupational therapy techniques such as neuro-developmental techniques with emphasis on functional tasks and muscle strengthening. The treatment protocol will include (1) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques for 15 to 20 minutes, (2) fine motor or dexterity training for 20 minutes, (3) arm exercises or gross motor training for 20 minutes, (4) muscle strengthening of the affected upper limb for 15 to 20 minutes, and (5) activities of daily living or functional tasks training for 15 to 20 minutes.

Treatment:

Behavioral: Dose-matched control therapy