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

NCT01908361 | Withdrawn

• 1 other identifier: 02-M04-022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Keywords

comparative efficacy research; combination therapy; neurorehabilitation; robotic rehabilitation; restraint therapy

Outcome Measures

Primary Outcomes (2)

• Change in Fugl-Meyer Assessment (FMA)

  The upper-extremity subscale of the FMA will be used to assess motor impairment. The 33 upper limb items measure the movement and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully). The maximum score is 66, indicating optimal recovery. The sub-score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements. The reliability, validity, and responsiveness of the FMA in stroke patients have been shown to be good.

  Baseline, 3 weeks, 6 weeks, and 18 weeks

• Change in Wolf Motor Function Test (WMFT)

  The WMFT was originally designed to assess the effects of CIT on the return of arm function for stroke and traumatic brain injury. The assessment requires the participant to perform 15 function-based and 2 strength-based tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds. For functional ability scoring, we used a 6-point ordinal scale where 0 indicates "does not attempt with the involved arm" and 5 indicates "arm does participate; movement appears to be normal." The clinimetrics of the WMFT has been ascertained in stroke patients.

  Baseline, 3 weeks, 6 weeks, and 18 weeks

Secondary Outcomes (10)

• Change in MyotonPro

  Baseline, 3 weeks, 6 weeks, and 18 weeks

• Change in 10-Meter Walk Test (10MWT)

  Baseline, 3 weeks, 6 weeks, and 18 weeks

• Change in Actigraphy

  Baseline, 3 weeks, 6 weeks, and 18 weeks

• Change in Functional Independence Measure (FIM)

  Baseline, 3 weeks, 6 weeks, and 18 weeks

• Change in Motor Activity Log (MAL)

  Baseline, 3 weeks, 6 weeks, and 18 weeks

Study Arms (3)

Unilateral Hybrid (InMotion3 plus CIT) Intervention

EXPERIMENTAL

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

Behavioral: Unilateral Hybrid (InMotion3 plus CIT) Intervention

Bilateral Hybrid (BMT plus BAT) Intervention

EXPERIMENTAL

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.

Behavioral: Bilateral Hybrid (BMT plus BAT) Intervention

Conventional Rehabilitation (CR)

ACTIVE COMPARATOR

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

Behavioral: Conventional Rehabilitation

Interventions

Unilateral Hybrid (InMotion3 plus CIT) Intervention 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.

Unilateral Hybrid (InMotion3 plus CIT) Intervention

Bilateral Hybrid (BMT plus BAT) Intervention 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.

Bilateral Hybrid (BMT plus BAT) Intervention

Conventional Rehabilitation 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.

Also known as: CR

Conventional Rehabilitation (CR)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital Taipei Branch

New Taipei City, Taiwan, 23142, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

serum P-component; Methods; glycine N-choloyltransferase

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Keh-chung Lin, ScD

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

  PRINCIPAL INVESTIGATOR

• Yi-shiung Horng, PhD

  Buddhist Tzu Chi General Hospital Taipei Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

TW (1)