Is the Rehabilitation Robotic a Safe and Effective Choice for Stroke Patients?

NCT03290833 | Completed

• 1 other identifier: TenChenGH
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The effectiveness of robotic over conventional therapy is arguable and the best therapy strategy is still not clear. Basing on the existing evidence on motor learning and practice-induced neuroplasticity, the investigators plan to use an exoskeleton robotic hand to enhance the rehabilitation volume in the subacute stage of stroke patients. The robotic system allows intensive and customized training of hand and finger movements. The aim of this study is (1) to establish whether robot assisted therapy provides any additional motor recovery for the hand when administered during the subacute stage in a Chinese adult population diagnosed with stroke; (2) to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation in improving arm function abilities in subacute hemiplegic patients.

Conditions

Stroke

Keywords

Robotics; Stroke; Hand; neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer score

  The investigators used FMA scale to evaluate sensorimotor recovery of patients with particular attention to the hand and wrist section (maximum score=24) to assess the functional capacity of the affected hand.

  Change from baseline to 10 weeks

Secondary Outcomes (3)

• Change in Motricity Index (MI) scale

  Change from baseline to 10 weeks

• Change in Functional Independence Measure scale (FIM)

  Change from baseline to 10 weeks

• Change in Visual analogue scale (VAS)

  Change from baseline to 10 weeks

Study Arms (2)

Robotic

EXPERIMENTAL

The experimental group will receive 30 minutes robotic training sessions, 3 times per week for a total of 30 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive schedule (1-hour sessions, 3 times/week, 30 total sessions) of conventional therapy from an occupational therapist.

Device: Robotic; Other: Conventional therapy

Conventional

ACTIVE COMPARATOR

In conventional therapy group, participants will receive an one-hour of one-on-one treatment (1-hour sessions, 3 times/week, 30 total sessions) from an occupational therapist, focusing on arm and hand function.

Other: Conventional therapy

Interventions

Robotic DEVICE

Participants will be placed in the robot and practice common hand tasks involving single finger range of motion exercise, grasping, and pinching objects.

Also known as: Conventional therapy

Robotic

Conventional therapy OTHER

An occupational therapist will provide one-on-one individualized programs focused on arm and hand function. Treatment will include function-oriented specific tasks, such as reach, grasp, transport and release of various objects between different targets.

Conventional; Robotic

Eligibility Criteria

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

You may qualify if:

• Adult patients (\>20 years old) with a diagnosis of hemorrhagic or ischemic stroke and who experience severe upper extremity hemiparesis.

You may not qualify if:

• severe pain and instability in the wrist of the affected arm, severe cognitive impairment, aphasia, hemispatial neglect, apraxia and joint contractures greater than 20 degrees in the affected hand.

Sponsors & Collaborators

• Ten-Chen General Hospital: lead
• Chung Yuan Christian University: collaborator

Study Sites (1)

Ten Chan General Hospital

Taoyuan, 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

• Chia-yu Hsu, MD

  Ten-Chan General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 25, 2017
• Study Start: November 24, 2017
• Primary Completion: June 9, 2019
• Study Completion: June 9, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)