Effectiveness of Robot-assisted Rehabilitation in Persons With Stroke

NCT04002076 | Unknown

• 1 other identifier: N201904042
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate the effects of robot-assisted hand with visual feedback intervention on cortical excitability, brain structure, spasiticity, gross and fine motor of upper limb and hand in individuals with stroke. Twenty participants will be recruited in this study. They will be allocated to two group: robot-assisted hand combined with traditional occupational therapy group (10), only traditional occupational therapy group (10).

Conditions

Stroke

Keywords

stroke; Robot-assisted Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change of Box and Block Test (BBT)

  Box and Block Test is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box should be oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. In order to practice and register baseline scores, the test should begin with the unaffected upper limb.

  Measurement before and after intervention ( week 0 and at the end of week 6) in both groups

• Change of Motor evoked potential (MEP)

  Motor evoked potential (MEP) is recorded from abductor pollicis brevis muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their one hand in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points along the M1. The optimal site is the location on the M1 that evoked the greatest MEP amplitude in abductor pollicis brevis muscles. The onset latency and onset to peak amplitude will be assessed.

  [Time Frame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups]

Secondary Outcomes (3)

• Change of Purdue Pegboard Test (PPT)

  Measurement before and after intervention ( week 0 and at the end of week 6) in both groups

• Change of Modified Ashworth Scale (MAS)

  Measurement before and after intervention ( week 0 and at the end of week 6) in both groups

• Change of Fugl-Meyer Assessment (FMA)-Upper extremity

  Measurement before and after intervention ( week 0 and at the end of week 6) in both groups

Study Arms (2)

Robot-assisted hand combined with occupational therapy

EXPERIMENTAL

Ten participants in group A will undergo robot-assisted hand (with visual feedback) combined with occupational therapy. They will receive 60 minutes a day and 3 days a week robot-assisted hand and occupational therapy for six weeks.

Behavioral: Robot-assisted hand combined with occupational therapy

Traditional occupational therapy

ACTIVE COMPARATOR

Another 10 participants allocated to the group B will receive 60 minutes a day and 3 days a week traditional occupational therapy for six weeks.

Behavioral: Traditional occupational therapy

Interventions

Robot-assisted hand combined with occupational therapy BEHAVIORAL

Robot-assisted hand group contains 15 minutes of grasp and release motion, 15 minutes of visual feedback training and 30 minutes traditions occupational therapy. Traditional occupational therapy includes cognition training, sensory-motor function therapy, passive ROM exercise, functional hand training, activity of daily living skill training, instruction of using assistive devices,and so on.

Robot-assisted hand combined with occupational therapy

Traditional occupational therapy BEHAVIORAL

Occupational therapy contains 60 minutes of traditional occupational therapy, which includes cognition training, sensory-motor function therapy, passive ROM exercise, functional hand training, activity of daily living skill training, instruction of using assistive devices,and so on.

Traditional occupational therapy

Eligibility Criteria

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

You may qualify if:

• Mini-Mental State Examination score is above 23
• A first-ever stroke with unilateral hemiplegia or hemiparesis.
• Medical and psychological condition is stable.

You may not qualify if:

• Balance and walking ability affected by other neurological problems
• Functional performance affected by medication or medical condition 3 Unable to tolerate rehabilitation.
• \. Severe hearing or visual problem. 5. Having pacemaker.

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical university Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

Chien-Hung Lai, MD PhD

CONTACT

886-2-27372181; chlai@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: June 28, 2019
• Study Start: August 7, 2019
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

TW (1)