Comparative Efficacy Research of Robot-Assisted Therapy With and Without Constraint-Induced Therapy in Stroke Rehabilitation

NCT01907139 | Completed

• 1 other identifier: 01-M07-072
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

There are 3 specific study purposes. First, we will examine the treatment effects of RT combined with dCIT (RT + dCIT) compared to RT, dCIT, and a dose-matched control therapy (DMCT) in stroke patients. Outcome domains will include motor, sensory, and muscle functions, amount of arm activity in real-life situations, patient-reported outcomes of daily performance and quality of life, and kinematic performance. Additionally, potential adverse effects including fatigue, pain, and a biomarker of oxidative stress will be examined. Second, we will investigate if the demographical and clinical characteristics of stroke patients may predict the probability of achieving clinically important changes of treatment outcomes. Thirdly, this study will examine whether the improvements after treatment reach clinically important or not and assess clinimetric properties of the outcome measures.

Conditions

Cerebrovascular Accident

Keywords

comparative efficacy research; combination therapy; neurorehabilitation; robot-assisted therapy; constraint-induced therapy

Outcome Measures

Primary Outcomes (5)

• 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, 2 weeks, and 4 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, 2 weeks, and 4 weeks

• Change in Functional Independence Measure (FIM)

  The FIM consists of 18 items grouped into 6 subscales measuring self-care, sphincter control, transfer, locomotion, communication, and social cognition ability. Each item is rated from 1 to 7 (maximum score 126) based on the required level of assistance to perform the tasks (e.g., 1-complete assistance and 7-complete independence). A higher score on any subscale indicates a less disability. The FIM has been shown to have good inter-rater reliability, construct validity, and discriminant validity.

  Baseline, 2 weeks, and 4 weeks

• Change in Motor Activity Log (MAL)

  The MAL consists of 30 structured questions to interview how the patients rate the frequency (amount of use subscale) and quality (quality of movement subscale) of movements while using their affected arm to accomplish each of the 30 daily activities. The score of each item ranges from 0 to 5, and the higher scores indicate more frequently used or higher quality of movements. The summary score is the mean of the item scores. The clinimetric properties of the MAL in stroke patients have been validated.

  Baseline, 2 weeks, and 4 weeks

• Change in Stroke Impact Scale Version 3.0 (SIS 3.0)

  The SIS 3.0 is a stroke-specific instrument of health-related quality of life. It contains 59 items measuring 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week. The reliability, validity, and responsiveness have been shown to be satisfactory in stroke patients.

  Baseline, 2 weeks, and 4 weeks

Secondary Outcomes (8)

• Change in Medical Research Council scale (MRC)

  Baseline, 2 weeks, and 4 weeks

• Change in Modified Ashworth Scale (MAS)

  Baseline, 2 weeks, and 4 weeks

• Change in Revised Nottingham Sensory Assessment (RNSA)

  Baseline, 2 weeks, and 4 weeks

• Change in MyotonPRO

  Baseline, 2 weeks, and 4 weeks

• Change in Actigraphy

  Baseline, 2 weeks, and 4 weeks

Study Arms (4)

Distributed constraint-induced therapy (dCIT)

EXPERIMENTAL

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.

Behavioral: Distributed constraint-induced therapy

Robot-assisted therapy (RT)

EXPERIMENTAL

The ArmeoSpring (Hocoma AG, Switzerland) will be adopted in this study. 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. The ArmeoSpring g provides weight support for the arm across a large 3D workspace, enabling naturalistic movement across approximately 66% of the normal workspace in the vertical plane and 72% in the horizontal plane. Its main structure consists of an arm exoskeleton with elastic bands that relieve the weight of the limb and provide a sense of arm flotation at all positions in the available workspace. A custom grip sensor consisting of a water-filled cylindrical bladder detects grip pressure and finger movement and allows incorporation of grasp and release practice into arm training.

Behavioral: Robot-assisted therapy

Dose-matched control therapy (DMCT)

ACTIVE COMPARATOR

The DMCT group mediated by the therapists will be designed to control for the duration of therapy in amount of therapy hours. 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.

Behavioral: Dose-matched control therapy

RT + dCIT

EXPERIMENTAL

In this combination therapy group, the participants will received 2 weeks of RT using the ArmeoSpring and followed by 2 weeks of distributed CIT. The treatment principles of RT and distributed CIT are the same with those described in the monotherapy of RT or dCIT, respectively. This combined intervention group may integrate proximal (shoulder and elbow) to distal (wrist and hand) training of the UL and help transfer from motor ability gained to functional performance improvement. That is, it appears to associate with the advantages/effects of each RT and dCIT intervention.

Behavioral: Robot-assisted therapy; Behavioral: Distributed constraint-induced therapy

Interventions

Robot-assisted therapy BEHAVIORAL

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. Games were designed to simulate functional arm movements to provide training in a simple virtual reality environment. Vu Therapy games were developed with the goal of enabling repetitive task-specific practice including grocery shopping, cleaning a stovetop, and playing basketball. In this way, stroke patients who are unable to use their severely weakened arms in a functional way are able to practice task-specific movements in a simulated, gravity-reduced environment. Auditory and visual feedback is provided throughout game play to maintain the patient's attention and motivation. In addition, users are provided objective feedback of task performance at the end of each game to enhance motivation and awareness of progress.

Also known as: RT

RT + dCIT; Robot-assisted therapy (RT)

Distributed constraint-induced therapy BEHAVIORAL

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. The shaping techniques will involve individualized task selection, graded task difficulty (e.g., practicing deficient parts of the selected activity and then performing the entire activity), verbal feedback, prompting, physical assistance with movements, and modeling. The level of challenge will be adapted based on patient ability and improvement. Participants will be also required to place their unaffected hand and wrist in a mitt for 6 hours a day during the 4-week period and document mitt compliance in daily logs.

Also known as: dCIT

Distributed constraint-induced therapy (dCIT); RT + dCIT

Dose-matched control therapy BEHAVIORAL

The DMCT group mediated by the therapists will be designed to control for the duration of therapy in amount of therapy hours. 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) tasks for training fine motor or dexterous function for 20 minutes, (3) arm exercises or gross motor training for 20 minutes, (4) muscle strengthening of the affected UL for 15 to 20 minutes, and (5) activities of daily living or functional tasks practice for 15 to 20 minutes. The activities will be adapted based on the level of motor impairment and individual needs of the patients.

Also known as: DMCT

Dose-matched control therapy (DMCT)

Eligibility Criteria

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

You may qualify if:

• months onset from a first-ever unilateral stroke
• an initial UL subsection of the Fugl-Meyer Assessment score of 20 to 56
• minimal motor criteria to receive CIT (i.e., ≥ 100 wrist extension and ≥ 100 extension at the thumb and any two other digits)
• 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)
• welling to provide written informed consent

You may not qualify if:

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

Condition Hierarchy (Ancestors)

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

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 16, 2013
• First Posted: July 24, 2013
• Study Start: August 1, 2013
• Primary Completion: July 31, 2016
• Study Completion: July 31, 2016
• Last Updated: February 3, 2017

Record last verified: 2016-01

Locations

TW (1)