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Completed

NCT Number: NCT03713476

Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation

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.

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Key information

Conditions

Rehabilitation, Tenodesis, Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motor task training

Other

motor task specific training

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2018
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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