Hybrid Approach to Unilateral vs. Bilateral Upper Limb Rehabilitation in Subacute and Chronic Stroke

NCT ID: NCT01908361

Last Updated: 2014-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-12-31

Brief Summary

In the unilateral vs. bilateral hybrid rehabilitation trials, we will conduct two separate clinical trials: one to recruit subacute stroke patients and another to recruit chronic stroke patients. The two trials will have identical study designs and interventions. The overall goal of this research project is to provide scientific evidence of the treatment effects of unilateral and bilateral hybrid therapies in subacute and chronic stroke patients and thus to contribute to evidence-based stroke rehabilitation and translational research for neurorehabilitation.

Detailed Description

The first aim of the project will be to compare treatment effects between hybrid rehabilitation and conventional rehabilitations (CR) on motor function, daily functions, mobility, quality of life, and kinematic variables. We hypothesize that patients receiving hybrid rehabilitation will gain more recovery than patients receiving CR in proximal (e.g., motor function) and in distal outcomes (e.g., quality of life) and that patients in the hybrid rehabilitation groups will show more genuine upper extremity motor recovery than those in conventional rehabilitation groups, as indicated by kinematic measures.

The second aim will be to examine the comparative treatment effects between unilateral hybrid and bilateral hybrid rehabilitation on various aspects of outcomes. We hypothesize that the unilateral group will improve more on outcomes associated with distal upper limb (UL) control and that the bilateral rehabilitation group will improve more on outcomes associated with proximal UL control.

Third, we will collect biomarker indexes before and after the interventions to monitor the changes of oxidative stress and inflammatory levels.

Conditions

Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Unilateral Hybrid (InMotion3 plus CIT) Intervention

Participants will receive 3 weeks of robot-assisted therapy (RT) using the InMotion3 Wrist Robot, followed by 3 weeks of CIT training.

Group Type: EXPERIMENTAL

Unilateral Hybrid (InMotion3 plus CIT) Intervention

Intervention Type: BEHAVIORAL

During the 3-week InMotion3 period, participants will receive 5 minutes of muscle tone normalization preparation and passive range of motion, then 85 minutes of training using the InMotion3 robot. The participants will practice about 5 to 8 minutes of passive, 30 to 35 minutes of assisted-active, and 5 to 8 minutes of active motions in wrist and forearm, respectively.

During the 3-week CIT period, participants will receive intensive training of the affected UL in functional tasks with behavioral shaping for 1.5 hours/weekday and will be asked to wear a mitt to restrict the unaffected UL for 6 hours daily. The shaping techniques will involve individualized task selection, graded task difficulty, verbal feedback, prompting, physical assistance with movements, and modeling. Caregivers will use daily logs to document hours of mitt wearing outside the one-on-one intervention sessions.

Bilateral Hybrid (BMT plus BAT) Intervention

Participants in this bilateral treatment group will receive 3 weeks of RT using the Bi-Manu-Track (BMT) robot (Reha-Stim Co., Berlin, Germany), followed by 3 weeks of therapist-based BAT.

Group Type: EXPERIMENTAL

Bilateral Hybrid (BMT plus BAT) Intervention

Intervention Type: BEHAVIORAL

During the 3-week BMT period, patients will play a simple computer game (e.g., picking up apples) that tracks patient movements to provide instant visual feedback. The therapist will also provide verbal feedback. In each training session, the patient will practice 600 to 800 repetitions of passive-passive mode for 15 minutes, 600 to 800 repetitions of active-passive mode for 15 to 20 minutes, and 150 to 200 repetitions of active-active mode for 5 minutes, respectively, for the forearm pronation-supination and the wrist flexion-extension.

During the 3-week BAT period, participants will receive training in tasks focusing on bilateral symmetric or alternating movements of both ULs, such as lifting two cups, picking up two pegs, grasping and releasing two towels, and wiping the table with both hands.

Conventional Rehabilitation (CR)

The CR intervention will be designed to match the duration and intensity of the hybrid interventions.

Group Type: ACTIVE_COMPARATOR

Conventional Rehabilitation

Intervention Type: BEHAVIORAL

Participants in CR group will receive therapist-mediated functional tasks training based on neurodevelopmental techniques with emphasis on functional tasks and muscle strengthening that will involve (1) active/passive range of motions, abnormal muscle tone/reflex inhibition techniques (such as stretching and/or weight bearing), and strengthening of affected arm for 15 to 20 minutes, (2) functional tasks for training fine motor or manual dexterity for 20 minutes, and (3) activities of daily living or functional tasks involving gross motor activities, coordination tasks, transition, mobility, and posture/balance for 15 to 20 minutes. The activities will be individualized according to the level of impairment and the needs of the patients.

Interventions

Unilateral Hybrid (InMotion3 plus CIT) Intervention

During the 3-week InMotion3 period, participants will receive 5 minutes of muscle tone normalization preparation and passive range of motion, then 85 minutes of training using the InMotion3 robot. The participants will practice about 5 to 8 minutes of passive, 30 to 35 minutes of assisted-active, and 5 to 8 minutes of active motions in wrist and forearm, respectively.

During the 3-week CIT period, participants will receive intensive training of the affected UL in functional tasks with behavioral shaping for 1.5 hours/weekday and will be asked to wear a mitt to restrict the unaffected UL for 6 hours daily. The shaping techniques will involve individualized task selection, graded task difficulty, verbal feedback, prompting, physical assistance with movements, and modeling. Caregivers will use daily logs to document hours of mitt wearing outside the one-on-one intervention sessions.

Intervention Type: BEHAVIORAL

Bilateral Hybrid (BMT plus BAT) Intervention

During the 3-week BMT period, patients will play a simple computer game (e.g., picking up apples) that tracks patient movements to provide instant visual feedback. The therapist will also provide verbal feedback. In each training session, the patient will practice 600 to 800 repetitions of passive-passive mode for 15 minutes, 600 to 800 repetitions of active-passive mode for 15 to 20 minutes, and 150 to 200 repetitions of active-active mode for 5 minutes, respectively, for the forearm pronation-supination and the wrist flexion-extension.

During the 3-week BAT period, participants will receive training in tasks focusing on bilateral symmetric or alternating movements of both ULs, such as lifting two cups, picking up two pegs, grasping and releasing two towels, and wiping the table with both hands.

Intervention Type: BEHAVIORAL

Conventional Rehabilitation

Participants in CR group will receive therapist-mediated functional tasks training based on neurodevelopmental techniques with emphasis on functional tasks and muscle strengthening that will involve (1) active/passive range of motions, abnormal muscle tone/reflex inhibition techniques (such as stretching and/or weight bearing), and strengthening of affected arm for 15 to 20 minutes, (2) functional tasks for training fine motor or manual dexterity for 20 minutes, and (3) activities of daily living or functional tasks involving gross motor activities, coordination tasks, transition, mobility, and posture/balance for 15 to 20 minutes. The activities will be individualized according to the level of impairment and the needs of the patients.

Intervention Type: BEHAVIORAL

Other Intervention Names

CR

Eligibility Criteria

Inclusion Criteria

• 1 to 6 months onset from a first-ever unilateral stroke for the subacute randomized controlled trial (RCT), and more then 6 months after onset for the chronic RCT
• minimal motor criteria to receive CIT (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits)
• an initial FMA-UE score of 18 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment
• no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers)
• able to follow instructions and perform the study tasks (Mini Mental State Examination ≥ 24)
• without upper extremity fracture within 3 months
• no participation in any rehabilitation experiments or drug studies during the study period
• willing to provide written informed consent

Exclusion Criteria

• acute inflammatory disease
• major health problems or poor physical condition that might limit participation

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keh-chung Lin, ScD

Role: PRINCIPAL_INVESTIGATOR

School of Occupational Therapy, College of Medicine, National Taiwan University, Taiwan

Yi-shiung Horng, PhD

Role: PRINCIPAL_INVESTIGATOR

Buddhist Tzu Chi General Hospital Taipei Branch

Locations

Buddhist Tzu Chi General Hospital Taipei Branch

New Taipei City, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

02-M04-022

Identifier Type: -

Identifier Source: org_study_id