Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation

Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation for Upper Extremity Function of Stroke Patients

In the proposed study, the investigators assumed that using robot assisted tenodesis-grip training providing high does assisted grip movement may do the effects on motor shaping and greater brain priming for hand paresis of the stroke patients. The specific aim of this study is to examine the difference in the treatment effects between the combination of robot assisted tenodesis-grip training with task-oriented training and combination of traditional occupational therapy with task-oriented training on the motor, sensation, hand performance of the stroke patients. The expected outcomes of this research are to help the clinicians understand the training mechanism and effects of robot assisted tenodesis-grip training on functional performance of upper extremity for unilateral stroke patients.

Study Overview

• Status: Completed
• Conditions: Rehabilitation, Tenodesis, Stroke
• Intervention / Treatment: Other: Motor task training

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng-Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Clinical diagnosis of stroke with unilateral side involved;
2. Stroke at least 7 days before the start of the first assessment session;
3. A score of Mini-mental state examination greater than 24 for proving higher mental function;
4. Premorbid right-handedness.

Exclusion Criteria:

1. Uncontrolled hypertension;
2. Major cognitive-perceptual deficit;
3. Other brain disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-assisted training; The participants will receive 20 minutes of robot assisted tenodesis-grip therapy, followed by 20 minutes of regular motor task specific training in each treatment session.	Other: Motor task training; motor task specific training
Active Comparator: Traditional occupational therapy; The participants will receive 20 minutes of traditional occupational therapy (sensorimotor facilitation techniques, such as: Rood, Bobath and propriocetive-neuromuscular-facilitation), followed by 20 minutes of motor task specific training in each treatment session.	Other: Motor task training; motor task specific training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the result of Box and blocks test	The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.	baseline, 6 weeks and 18 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test	The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.	baseline, 6 weeks and 18 weeks
Change in the result of Fugl-Meyer assessment for UE motor function	Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.	baseline, 6 weeks and 18 weeks
Change in the result of Modified Ashworth scale (MAS)	Muscle tone is defined by the resistance of a muscle being stretched without resistance.	baseline, 6 weeks and 18 weeks
Change in the result of Motor Activity Log	MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.	baseline, 6 weeks and 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical global impression scale	Self-reported improvement over the treatment period,. The scale, rated from 1 (very much improved) to 7 (very much worse), is as the indicator for determining perceptible change of the patients for assisted tenodeis-grip robot system.	post-intervention (week 6)

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Publications and helpful links

General Publications

• Hsu HY, Yang KC, Yeh CH, Lin YC, Lin KR, Su FC, Kuo LC. A Tenodesis-Induced-Grip exoskeleton robot (TIGER) for assisting upper extremity functions in stroke patients: a randomized control study. Disabil Rehabil. 2022 Nov;44(23):7078-7086. doi: 10.1080/09638288.2021.1980915. Epub 2021 Sep 29.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): March 20, 2024

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: B-BR-106-074-T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No