Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Motor task specific training

About this trial

This is an interventional treatment trial for Rehabilitation, Tenodesis, Stroke

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

National Cheng-Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot-assisted training

Traditional occupational therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Change in the result of Modified Ashworth scale (MAS)

Muscle tone is defined by the resistance of a muscle being stretched without resistance.

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.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03713476

First Posted

October 18, 2018

Last Updated

March 22, 2023

Sponsor

National Cheng-Kung University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03713476

Brief Title

Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 3, 2018 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rehabilitation, Tenodesis, Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Robot-assisted training

Arm Type

Experimental

Arm Description

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.

Arm Title

Traditional occupational therapy

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Motor task specific training

Intervention Description

Motor training targeted to goals that are relevant to the functional needs of the patient

Primary Outcome Measure Information:

Title

Change in the result of Fugl-Meyer assessment for UE motor function

Description

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.

Time Frame