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Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation

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ClinicalTrials.gov Identifier: NCT03713476
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

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.

Condition or disease Intervention/treatment Phase
Rehabilitation, Tenodesis, Stroke Other: Motor task specific training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation for Upper Extremity Function of Stroke Patients
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

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

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




Primary Outcome Measures :
  1. Change in the result of Fugl-Meyer assessment for UE motor function [ Time Frame: baseline, 6 weeks and 18 weeks ]
    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.

  2. Change in the result of Modified Ashworth scale (MAS) [ Time Frame: baseline, 6 weeks and 18 weeks ]
    Muscle tone is defined by the resistance of a muscle being stretched without resistance.

  3. Change in the result of Box and blocks test [ Time Frame: baseline, 6 weeks and 18 weeks ]
    The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.

  4. Change in the result of Semmes-Weinstein monofilament (SWM) test [ Time Frame: baseline, 6 weeks and 18 weeks ]
    The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.

  5. Change in the result of Motor Activity Log [ Time Frame: baseline, 6 weeks and 18 weeks ]
    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 :
  1. Clinical global impression scale [ Time Frame: post-intervention (week 6) ]
    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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713476


Locations
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Taiwan
National Cheng-Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Hsiu-Yun Hsu, Ph.D.    886-6-2353535 ext 2669    hyhsu@mail.ncku.edu.tw   
Sponsors and Collaborators
National Cheng-Kung University Hospital

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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT03713476     History of Changes
Other Study ID Numbers: B-BR-106-074-T
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases