Rehabilitation, Tenodesis, StrokeNCT03713476
Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation
A study testing Motor task training in people with Rehabilitation, Tenodesis, Stroke, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rehabilitation, Tenodesis, Stroke
- What is being tested?
- Motor task training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Dec 2018to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Uncontrolled hypertension;
- Major cognitive-perceptual deficit;
- Other brain disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation for Upper Extremity Function of Stroke Patients
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.
- Conditions
- Rehabilitation, Tenodesis, Stroke
- Being tested
- Motor task training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor task trainingOther
motor task specific training
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted training | Experimental | 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. Receives: Other: Motor task training |
| Traditional occupational therapy | Active comparator | 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. Receives: Other: Motor task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 weeks and 18 weeks
Change in the result of Modified Ashworth scale (MAS)
Muscle tone is defined by the resistance of a muscle being stretched without resistance.
Measured: baseline, 6 weeks and 18 weeks
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.
Measured: baseline, 6 weeks and 18 weeks
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.
Measured: baseline, 6 weeks and 18 weeks
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.
Measured: baseline, 6 weeks and 18 weeks
Secondary outcomes (1)
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.
Measured: post-intervention (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start3 Dec 2018
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rehabilitation, Tenodesis, StrokeStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713476
- Sponsor's protocol ID
- B-BR-106-074-T
- Status last verified
- Mar 2023
- First submitted
- 18 Oct 2018
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38173006Hsu 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.
PubMed 34586927
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation for Upper Extremity Function of Stroke Patients
- ClinicalTrials.gov ID
- NCT03713476
- Acronym / sponsor ID
- B-BR-106-074-T
- Conditions
- Rehabilitation, Tenodesis, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted training | Experimental | Other: Motor task trainingThe 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. |
| Traditional occupational therapy | Active comparator | Other: Motor task trainingThe 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Uncontrolled hypertension;
- Major cognitive-perceptual deficit;
- Other brain disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor task trainingmotor task specific training | Other | Robot-assisted training, Traditional occupational therapy |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Clinical global impression scale
Time frame: post-intervention (week 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 38173006Hsu 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.
- Derived from this study: PubMed 34586927Hsu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor task training in people with Rehabilitation, Tenodesis, Stroke, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the result of Fugl-Meyer assessment for UE motor function (time frame: baseline, 6 weeks and 18 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713476, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.