Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation

NCT ID: NCT03713476

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2024-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Rehabilitation, Tenodesis, Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Motor task training

Intervention Type OTHER

motor task specific training

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.

Group Type ACTIVE_COMPARATOR

Motor task training

Intervention Type OTHER

motor task specific training

Interventions

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Motor task training

motor task specific training

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cheng-Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

References

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Hsu HY, Koh CL, Yang KC, Lin YC, Hsu CH, Su FC, Kuo LC. Effects of an assist-as-needed equipped Tenodesis-Induced-Grip Exoskeleton Robot (TIGER) on upper limb function in patients with chronic stroke. J Neuroeng Rehabil. 2024 Jan 3;21(1):5. doi: 10.1186/s12984-023-01298-2.

Reference Type DERIVED
PMID: 38173006 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34586927 (View on PubMed)

Other Identifiers

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B-BR-106-074-T

Identifier Type: -

Identifier Source: org_study_id

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