Skip to content

Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03713476
Enrollment
38
Registered
2018-10-19
Start date
2018-12-03
Completion date
2024-03-20
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation, Tenodesis, Stroke

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.

Interventions

OTHERMotor task training

motor task specific training

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the result of Fugl-Meyer assessment for UE motor functionbaseline, 6 weeks and 18 weeksEach 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)baseline, 6 weeks and 18 weeksMuscle tone is defined by the resistance of a muscle being stretched without resistance.
Change in the result of Box and blocks testbaseline, 6 weeks and 18 weeksThe 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) testbaseline, 6 weeks and 18 weeksThe 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 Logbaseline, 6 weeks and 18 weeksMAL 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

MeasureTime frameDescription
Clinical global impression scalepost-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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026