Effects of RAT in Sequential Combination With CIT in Stroke Rehabilitation

NCT01727648 | Unknown

• 1 other identifier: 201112104RIB
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebrovascular Accident

Keywords

Stroke rehabilitation; Comparative efficacy research; Combined therapy; Robot-Assisted Therapy; Constraint-Induced Therapy; Kinematic analysis

Outcome Measures

Primary Outcomes (1)

• 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.

  An expected average of 4 weeks

Secondary Outcomes (10)

• Functional Independence Measure (FIM)

  An expected average of 4 weeks

• Stroke Impact Scale Version 3.0 (SIS 3.0)

  An expected average of 4 weeks

• Visual analogue scale (VAS) for assessing post-exertional fatigue and pain

  An expected average of 4 weeks

• Actigraphy

  An expected average of 4 weeks

• Motor Status Score (MSS)

  An expected average of 4 weeks

Study Arms (4)

RT in sequential combination with dCIT

EXPERIMENTAL

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.

Behavioral: RT in sequential combination with dCIT

Distributed Constraint-Induced Therapy

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. Participants in this group will focus on the intensive training of the affected arm in functional activities with behavioral shaping.

Behavioral: Distributed Constraint-Induced Therapy

Robot-Assisted Therapy

EXPERIMENTAL

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.

Behavioral: Robot-Assisted Therapy

Dose-matched control therapy

ACTIVE COMPARATOR

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.

Behavioral: Dose-matched control therapy

Interventions

RT in sequential combination with dCIT BEHAVIORAL

The participants will received 2 weeks of RT therapy using the ArmeoSpring 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.

Also known as: RT+dCIT

RT in sequential combination with dCIT

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.

Also known as: dCIT

Distributed Constraint-Induced Therapy

Robot-Assisted Therapy BEHAVIORAL

Participants will receive 20 training sessions (1.5 hours/day, 5 days/week for 4 consecutive weeks). The ArmeoSpring (Hocoma AG, Switzerland) 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.

Also known as: RT

Robot-Assisted Therapy

Dose-matched control therapy BEHAVIORAL

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.

Also known as: DMCT

Dose-matched control therapy

Eligibility Criteria

• Age: 20 Years - 75 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 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

You may not qualify if:

• Exhibit 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

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (2)

• Hsieh YW, Liing RJ, Lin KC, Wu CY, Liou TH, Lin JC, Hung JW. Sequencing bilateral robot-assisted arm therapy and constraint-induced therapy improves reach to press and trunk kinematics in patients with stroke. J Neuroeng Rehabil. 2016 Mar 22;13:31. doi: 10.1186/s12984-016-0138-5.

  PMID: 27000446 DERIVED

• Hsieh YW, Lin KC, Horng YS, Wu CY, Wu TC, Ku FL. Sequential combination of robot-assisted therapy and constraint-induced therapy in stroke rehabilitation: a randomized controlled trial. J Neurol. 2014 May;261(5):1037-45. doi: 10.1007/s00415-014-7345-4. Epub 2014 Apr 20.

  PMID: 24748465 DERIVED

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keh-chung Lin, ScD

CONTACT

886-2-33668180; kehchunglin@ntu.edu.tw

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: April 23, 2012
• First Posted: November 16, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

TW (1)