StrokeNCT05841108
Effect of Task-oriented Training Assisted by Force Feedback Hand Rehabilitation Robot on Finger Function in Stroke Patients With Hemiplegia
A study testing force feedback rehabilitation robot (SEM™ Glove) and assisted by a therapist in people with Stroke, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Over eighty percent of stroke patients experience finger-grasping dysfunction problems, compromising independence in daily life activities and quality of life. In routine training, task-oriented training is usually used for functional training of the hand, which may improve the finger grasping performance after… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- force feedback rehabilitation robot (SEM™ Glove) and assisted by a therapist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2023to 10 Nov 2023
- 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
- First-ever stroke
- Aged 20~80 years old
- Post-stroke time≤6 months
- Clinically diagnosed with a central paresis of the right arm/hand (Brunnstrom stage of the affected upper limb≥II, Brunnstrom stage of the affected hand II~V, Active flexion range of motion of the affected finger joint≥10°, MAS of affected upper limb and finger≤1+
- Sitting balance≥Level 2
- No serious depression and no visual impairment
- Cognitive and speech abilities sufficient to understand instructions and to provide informed consent
Who cannot join
- Severe additional neurological, orthopedic, or rheumatoid impairments before stroke which could interfere with task performance
- Sensory disturbance of fingers
- Severe joint pain caused by various reasons affects the functional activities of fingers
- Complicated with serious heart, lung, liver, kidney or infection
- Attending another study or therapy to improve arm-hand function
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First hospital of Jilin University
Changchun
zhenlan li, 15943053720, zhenlan@jlu.edu.cn
About this study
Over eighty percent of stroke patients experience finger-grasping dysfunction problems, compromising independence in daily life activities and quality of life. In routine training, task-oriented training is usually used for functional training of the hand, which may improve the finger grasping performance after stroke, whereby augmented therapy may lead to a better treatment outcome. Technology-supported training holds opportunities for increasing training intensity. However, most of the hand rehabilitation robots commonly used in the clinic are based on passive training mode and lacks the sensory feedback function of fingers, which is not conducive to patients completing more accurate grasping movements. The force feedback hand rehabilitation robot can make up for the above defects, but its clinical efficacy in stroke patients are not known to date. The aim of the present study was to investigate the effectiveness and added value of the force feedback hand rehabilitation robot combined with task-oriented training for stroke patients with hemiplegia.
- Conditions
- Stroke
- Being tested
- force feedback rehabilitation robot (SEM™ Glove), assisted by a therapist
- Keywords
- Hand dysfunction, Force feedback hand rehabilitation robot, Task-oriented training, Neurorehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
force feedback rehabilitation robot (SEM™ Glove)Device
Also called SEM™ Glove
In the experimental group, the therapists were asked to illustrate and demonstrate the motor points of the cylindrical grasping and spherical grasping movements, and the patients were instructed to imitate them with nonparalytic hand, while the latter patients wore SEM™ Glove were used for task-oriented training, such as inserting pegs, grasping a ball into a barrel, and drinking water exercises. The difficulty of task-oriented training can be adjusted according to the patient's actual condition, such as changing the shape, weight, size of the target or changing the distance, duration, and so on during training
assisted by a therapistOther
The control group received task-oriented training assisted by a therapist to complete the same task as the experimental group. Therapists need to instruct patients to try to grasp items and give appropriate assistance to guarantee their completion of the grasping task. If finger extension is weak, the therapist assists the patient in extension of the digits before grasping the items, and if the finger flexion angle does not meet the grasp function needs, it should assist in flexion finger movements
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Device: force feedback rehabilitation robot (SEM™ Glove) |
| control group | Active comparator | Not described Receives: Other: assisted by a therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer motor function assessment-upper limb finger motor part
Fugl-meyer motor function assessment-upper limb (FMA-UL) has been found a reliable and valid test for the assessment of arm hand function in stroke patients. The maximum score of on the FMA-UL is 66 points. This study used FMA-UL finger motor part , with a total score of 14 points.
Measured: Change from baseline Fugl-Meyer motor function assessment-upper limb finger motor part score at 4 weeks
Secondary outcomes (5)
Modified Ashworth scale (MAS)
The Modified Ashworth scale (MAS) was used to rate muscle tone/stiffness during passive movement of the flexors of the fingers. The scale ranges from '0 = normal','1','1+','2','3', and '4= worst'. Participants were assessed in all sessions using this 6-point ordinal scale for the hand treated in the study
Measured: Change from baseline Modified Ashworth scale outcome at 4 weeks
Range of motion (ROM)
Range of motion (ROM) was measured with a goniometer. This study measures ROM of each finger, sum of five fingers flexion ROM, sum of five fingers extension ROM and total ROM of the five fingers. The ROM of each finger is the difference between the total ROM of each finger joint in the extension position and the total ROM of each finger joint in the flexion position. The sum of five finger flexion ROM is the sum of 14 finger joint flexion ROM. The sum of five finger extension ROM is the sum of 14 finger joint extension ROM. The total ROM of the five fingers is the difference between the total ROM of the extension position and the total ROM of the flexion position. The goniometer is used to measure the AROM of the affected hand first, and then the PROM.
Measured: Change from baseline range of motion outcome at 4 weeks
grip strength
Grip strength of the dominant hand was tested using an isometric hand dynamometer in the testing position recommended by American Society of Hand Therapists(ASHT). Participants gripped the dynamometer as hard as possible once without any jerking. The best score out of three consecutive trials was used for analyses. Sufficient time was allowed for the participants to recover from any fatigue related to grip testing
Measured: Change from baseline grip strength at 4 weeks
Brunnstrom recovery stages of hand (BRS-H)
Brunnstrom recovery stages of hand (BRS-H) classifies the motor function into 6 levels based on recovery stages from a flaccid limb to near-normal and normal movement and coordination. Higher levels indicate better motor function. This study, the I-VI levels of the motor function were assigned with a score from 1 to 6.
Measured: Change from baseline brunnstrom recovery stages of hand at 4 weeks
Barthel index (BI)
Barthel index contains 10 items and has a score range from 0 to 100, was used to assess activity and participation
Measured: Change from baseline barthel index at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start4 May 2023
- Primary completion10 Nov 2023 (estimated)
- Study completion10 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenlan li, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841108
- Sponsor's protocol ID
- 20220101
- Status last verified
- May 2023
- First submitted
- 14 Feb 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Y, Lian Y, Chen X, Zhang H, Xu G, Duan H, Xie X, Li Z. Effect of task-oriented training assisted by force feedback hand rehabilitation robot on finger grasping function in stroke patients with hemiplegia: a randomised controlled trial. J Neuroeng Rehabil. 2024 May 14;21(1):77. doi: 10.1186/s12984-024-01372-3.
PubMed 38745227
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Task-oriented Training Assisted by Force Feedback Hand Rehabilitation Robot on Finger Function in Stroke Patients With Hemiplegia
- ClinicalTrials.gov ID
- NCT05841108
- Acronym / sponsor ID
- 20220101
- Conditions
- Stroke
- Keywords
- Hand dysfunction, Force feedback hand rehabilitation robot, Task-oriented training, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 10 Nov 2023 (estimated)
- Study completion
- 10 Nov 2023 (estimated)
- First posted
- 3 May 2023 (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.
Over eighty percent of stroke patients experience finger-grasping dysfunction problems, compromising independence in daily life activities and quality of life. In routine training, task-oriented training is usually used for functional training of the hand, which may improve the finger grasping performance after stroke, whereby augmented therapy may lead to a better treatment outcome. Technology-supported training holds opportunities for increasing training intensity. However, most of the hand rehabilitation robots commonly used in the clinic are based on passive training mode and lacks the sensory feedback function of fingers, which is not conducive to patients completing more accurate grasping movements. The force feedback hand rehabilitation robot can make up for the above defects, but its clinical efficacy in stroke patients are not known to date. The aim of the present study was to investigate the effectiveness and added value of the force feedback hand rehabilitation robot combined with task-oriented training for stroke patients with hemiplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: force feedback rehabilitation robot (SEM™ Glove) |
| control group | Active comparator | Other: assisted by a therapist |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First-ever stroke
- Aged 20~80 years old
- Post-stroke time≤6 months
- Clinically diagnosed with a central paresis of the right arm/hand (Brunnstrom stage of the affected upper limb≥II, Brunnstrom stage of the affected hand II~V, Active flexion range of motion of the affected finger joint≥10°, MAS of affected upper limb and finger≤1+
- Sitting balance≥Level 2
Key exclusion criteria (5 listed)
- Severe additional neurological, orthopedic, or rheumatoid impairments before stroke which could interfere with task performance
- Sensory disturbance of fingers
- Severe joint pain caused by various reasons affects the functional activities of fingers
- Complicated with serious heart, lung, liver, kidney or infection
- Attending another study or therapy to improve arm-hand function
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 |
|---|---|---|
| force feedback rehabilitation robot (SEM™ Glove)Also: SEM™ GloveIn the experimental group, the therapists were asked to illustrate and demonstrate the motor points of the cylindrical grasping and spherical grasping movements, and the patients were instructed to imitate them with nonparalytic hand, while the latter patients wore SEM™ Glove were used for task-oriented training, such as inserting pegs, grasping a ball into a barrel, and drinking water exercises. The difficulty of task-oriented training can be adjusted according to the patient's actual condition, such as changing the shape, weight, size of the target or changing the distance, duration, and so on during training | Device | experimental group |
| assisted by a therapistThe control group received task-oriented training assisted by a therapist to complete the same task as the experimental group. Therapists need to instruct patients to try to grasp items and give appropriate assistance to guarantee their completion of the grasping task. If finger extension is weak, the therapist assists the patient in extension of the digits before grasping the items, and if the finger flexion angle does not meet the grasp function needs, it should assist in flexion finger movements | Other | control group |
Primary outcome
Fugl-Meyer motor function assessment-upper limb finger motor part
Time frame: Change from baseline Fugl-Meyer motor function assessment-upper limb finger motor part score at 4 weeks
Fugl-meyer motor function assessment-upper limb (FMA-UL) has been found a reliable and valid test for the assessment of arm hand function in stroke patients. The maximum score of on the FMA-UL is 66 points. This study used FMA-UL finger motor part , with a total score of 14 points.
5 secondary outcomes
Modified Ashworth scale (MAS)
Time frame: Change from baseline Modified Ashworth scale outcome at 4 weeks
Range of motion (ROM)
Time frame: Change from baseline range of motion outcome at 4 weeks
grip strength
Time frame: Change from baseline grip strength at 4 weeks
Brunnstrom recovery stages of hand (BRS-H)
Time frame: Change from baseline brunnstrom recovery stages of hand at 4 weeks
Barthel index (BI)
Time frame: Change from baseline barthel index at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 38745227Li Y, Lian Y, Chen X, Zhang H, Xu G, Duan H, Xie X, Li Z. Effect of task-oriented training assisted by force feedback hand rehabilitation robot on finger grasping function in stroke patients with hemiplegia: a randomised controlled trial. J Neuroeng Rehabil. 2024 May 14;21(1):77. doi: 10.1186/s12984-024-01372-3.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing force feedback rehabilitation robot (SEM™ Glove) and assisted by a therapist in people with Stroke, run by The First Hospital of Jilin University at 1 site in China.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhenlan li (15943053720, zhenlan@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer motor function assessment-upper limb finger motor part (time frame: Change from baseline Fugl-Meyer motor function assessment-upper limb finger motor part score at 4 weeks). 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 NCT05841108, which also lists 1 linked publication.
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 6 May 2023.