StrokeNCT04436627
Protocol Design of Hand Robotics Assisted Therapy in Patients With Different Severity of Stroke
A study testing Amadeo-assisted training-1, Amadeo-assisted training-2 and Amadeo-assisted training-3 in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Some studies have shown that the end-effector type of hand robotic-assisted therapy (RT) can effectively improve upper extremity (UE) motor function in patients with stroke. However, these studies provide insufficient information on treatment protocol, making it difficult for therapists to apply the RT in clinical… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Amadeo-assisted training-1, Amadeo-assisted training-2 and Amadeo-assisted training-3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Feb 2020to Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Unilateral stroke patients diagnosed by neurologists with stable life conditions
- (2) Twenty years old or older
- (3) Modified Ashworth Scale of proximal UE ≤ 3 (shoulder and elbow), and Modified Ashworth Scale of distal UE ≤ 2 (wrist and fingers)
- (4) UE subscale of Fugl-Meyer Assessment score < 60
- (5) Cognitive test with the Mini Mental State Examination ≥ 21
- (6) Can provide informed consent
Who cannot join
- (1) Joint contracture greater than 10° in the paretic wrist or hand
- (2) Absence of proprioception in the wrist and hand
- (3) Other neurological or psychological disorders, e.g. Parkinson's disease
- (4) Receiving Botulinum toxin injections within 3 months
- (5) Enrolling in other rehabilitation experiments or drug studies within 3 months
- (6) unable to operate the AMADEO training system or who may have safety concern
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan City, 333
Ching-Yi Wu, ScD, 886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw
Ching-Yi Wu, ScD
About this study
Some studies have shown that the end-effector type of hand robotic-assisted therapy (RT) can effectively improve upper extremity (UE) motor function in patients with stroke. However, these studies provide insufficient information on treatment protocol, making it difficult for therapists to apply the RT in clinical practice. This study aims to develop an end-effector RT treatment protocol and to examine the preliminary effects of the treatment protocol on UE motor function in patients with stroke.
Read the detailed description
There are two objectives in this case series study. One is combining external scientific evidence with clinical expertise to design a detailed training protocol for RT in patients with different severity of stroke. The other is to examine the effects on UE motor function and explore the client perspective.
The training protocol was developed based on the ACE Star Cycle Knowledge Transformation Model, which includes steps such as summarizing previous evidence and adjusting the protocol after practice by therapists. Purposive sampling will be used to recruit 35patients with stroke with different severities (Brunnstrom stage of distal part: 10 for stage II~III /10 for stage IV /15 for stage V~VI) from a regional hospital in Taiwan. Each participant will receive 12-15 sessions of 50-60 minutes intervention over 3 weeks. Motor function evaluations will be administered before and after the intervention. Wilcoxon Signed Rank test will be used to examine the change between the pretest and posttest.
- Conditions
- Stroke
- Being tested
- Amadeo-assisted training-1, Amadeo-assisted training-2, Amadeo-assisted training-3
- Keywords
- Stroke, Robotic 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.
Amadeo-assisted training-1Device
Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes active assistive training mode, followed by 20 minutes RT functional games (grasp and release) and 20 minutes RT finger coordination training.
Amadeo-assisted training-2Device
Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 10 minutes continuous passive motion mode followed by 20 minutes active assistive training mode, and 30 minutes RT functional games (grasp and release).
Amadeo-assisted training-3Device
Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes continuous passive motion mode followed by 20 minutes active assistive training mode. After 40 minutes of RT, 20 minutes functional tasks without robot.
| Study group | Role | What they receive |
|---|---|---|
| Mild severity: | Experimental | Brunnstrom stage of distal part: 5-6 Receives: Device: Amadeo-assisted training-1 |
| Moderate severity: | Experimental | Brunnstrom stage of distal part: 4 Receives: Device: Amadeo-assisted training-2 |
| severe severity: | Experimental | Brunnstrom stage of distal part: 2-3 Receives: Device: Amadeo-assisted training-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment, FMA
The UE subscale of Fugl-Meyer Assessment (UE-FMA) is used to evaluate the recovery of motor function of UE. FMA mainly evaluates the degree of synergy pattern during volitional movements, as well as reflex activity and coordination. UE-FMA consists of 33 items and the total motor score of UE-FMA is 66 points. The higher score means better motor function. FMA has good interrater reliability, good test-retest reliability, and moderate responsiveness.
Measured: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
Modified Ashworth scale of muscle spasticity, MAS
The Modified Ashworth Scale (MAS) is used to measure muscle spasticity of specific muscle groups of the paretic UE. We measure the muscle tone of proximal part (including shoulder and elbow) and distal part (including wrist and fingers). The grading of spasticity ranges from 0 to 4. A higher score indicates higher levels of spasticity. MAS is a reliable measurement with moderate to high interrater reliability and intrarater reliability.
Measured: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
Grip and pinch power
The electrical handgrip dynamometers (Jamar® Plus+ Hand Evaluation Kit) is used to assess the strength of hand grasp and lateral pinch (thumb and index) of both hands (distal part of UE). In each time of assessment, the patient grasp the handles in elbow flexion 90° and forearm in neutral position, and then make a maximum but stable power for about 5 seconds. Lateral pinch is assessed in a similar means. Each hand is assessed for three times in turns. Good accuracy (± 1-3%) and good reliability (inter-rater reliability and test-retest reliability) have been demonstrated.
Measured: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
Medical Research Council scale, MRC
The Medical Research Council scale (MRC) is used to assess muscle strength of the paretic UE. Eight muscle groups (including shoulder flexors, shoulder abductors, elbow flexors, elbow extensors, wrist flexors, wrist extensors, finger MP flexors, and finger MP extensors) is manually tested by the assessor. It is rated in a 6-point ordinal scale, and a higher score indicates stronger muscle.
MRC has very good inter-rater reliability and intra-rater reliability.
Measured: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
Wolf Motor Function Test, WMFT
The Wolf Motor Function Test (WMFT) is a time-based test that measures UE movements and movement speed during functional tasks. The test includes 15 function-based tasks and 2 strength-based tasks. WMFT has standard template printed on the table to assure the placement of test objects, and the positions of patients in each task are also standardized. The participant is asked to perform the tasks with the affected UE as independently as possible, and as quickly as possible. Two types of scores are recorded during the task: WMFT-TIME (completing time of the task) and WMFT-FAS (functional abilities of the paretic UE). The maximum score of WMFT-TIME is 120 seconds, and a higher score means a slower movement. WMFT-FAS is scored from 0 to 5, and a higher score means a higher level of functional performance, better quality, coordination or precision of paretic UE during the task. WMFT has high interrater reliability, internal consistency, and test-retest reliability.
Measured: Frame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
Nine-hole pegboard test, NPT
The Nine-hole pegboard test is used to measure finger dexterity of both UE. The participant is asked to take the pegs from a container (one by one), and place them into the holes on the board. After placing the pegs into nine holes, the participant needs to remove the pegs from the holes back into the container (one by one). All the process needs to be as quickly as possible. The NPT has very good interrater reliability and moderate to high test-retest reliability.
Measured: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
User experience
To understand the experience of using the robot-assisted therapy, a semi-structured interview is conducted to understand the patient's perspective. The interview takes about 10 minutes, recording and verbatim is used for further analysis.
Measured: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start7 Feb 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-yi Wu, ScD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436627
- Sponsor's protocol ID
- 201901693A3
- Status last verified
- May 2021
- First submitted
- 16 Jun 2020
- Last updated
- 17 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Design of Hand Robotics Assisted Therapy in Patients With Different Severity of Stroke
- ClinicalTrials.gov ID
- NCT04436627
- Acronym / sponsor ID
- 201901693A3
- Conditions
- Stroke
- Keywords
- Stroke, Robotic Training, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Jun 2020 (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.
Some studies have shown that the end-effector type of hand robotic-assisted therapy (RT) can effectively improve upper extremity (UE) motor function in patients with stroke. However, these studies provide insufficient information on treatment protocol, making it difficult for therapists to apply the RT in clinical practice. This study aims to develop an end-effector RT treatment protocol and to examine the preliminary effects of the treatment protocol on UE motor function in patients with stroke.
Detailed description
There are two objectives in this case series study. One is combining external scientific evidence with clinical expertise to design a detailed training protocol for RT in patients with different severity of stroke. The other is to examine the effects on UE motor function and explore the client perspective.
The training protocol was developed based on the ACE Star Cycle Knowledge Transformation Model, which includes steps such as summarizing previous evidence and adjusting the protocol after practice by therapists. Purposive sampling will be used to recruit 35patients with stroke with different severities (Brunnstrom stage of distal part: 10 for stage II~III /10 for stage IV /15 for stage V~VI) from a regional hospital in Taiwan. Each participant will receive 12-15 sessions of 50-60 minutes intervention over 3 weeks. Motor function evaluations will be administered before and after the intervention. Wilcoxon Signed Rank test will be used to examine the change between the pretest and posttest.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild severity: | Experimental | Device: Amadeo-assisted training-1Brunnstrom stage of distal part: 5-6 |
| Moderate severity: | Experimental | Device: Amadeo-assisted training-2Brunnstrom stage of distal part: 4 |
| severe severity: | Experimental | Device: Amadeo-assisted training-3Brunnstrom stage of distal part: 2-3 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (1) Unilateral stroke patients diagnosed by neurologists with stable life conditions
- (2) Twenty years old or older
- (3) Modified Ashworth Scale of proximal UE ≤ 3 (shoulder and elbow), and Modified Ashworth Scale of distal UE ≤ 2 (wrist and fingers)
- (4) UE subscale of Fugl-Meyer Assessment score < 60
- (5) Cognitive test with the Mini Mental State Examination ≥ 21
Key exclusion criteria (6 listed)
- (1) Joint contracture greater than 10° in the paretic wrist or hand
- (2) Absence of proprioception in the wrist and hand
- (3) Other neurological or psychological disorders, e.g. Parkinson's disease
- (4) Receiving Botulinum toxin injections within 3 months
- (5) Enrolling in other rehabilitation experiments or drug studies within 3 months
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 |
|---|---|---|
| Amadeo-assisted training-1Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes active assistive training mode, followed by 20 minutes RT functional games (grasp and release) and 20 minutes RT finger coordination training. | Device | Mild severity: |
| Amadeo-assisted training-2Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 10 minutes continuous passive motion mode followed by 20 minutes active assistive training mode, and 30 minutes RT functional games (grasp and release). | Device | Moderate severity: |
| Amadeo-assisted training-3Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes continuous passive motion mode followed by 20 minutes active assistive training mode. After 40 minutes of RT, 20 minutes functional tasks without robot. | Device | severe severity: |
Primary outcome
Fugl-Meyer Assessment, FMA
Time frame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
The UE subscale of Fugl-Meyer Assessment (UE-FMA) is used to evaluate the recovery of motor function of UE. FMA mainly evaluates the degree of synergy pattern during volitional movements, as well as reflex activity and coordination. UE-FMA consists of 33 items and the total motor score of UE-FMA is 66 points. The higher score means better motor function. FMA has good interrater reliability, good test-retest reliability, and moderate responsiveness.
Modified Ashworth scale of muscle spasticity, MAS
Time frame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
The Modified Ashworth Scale (MAS) is used to measure muscle spasticity of specific muscle groups of the paretic UE. We measure the muscle tone of proximal part (including shoulder and elbow) and distal part (including wrist and fingers). The grading of spasticity ranges from 0 to 4. A higher score indicates higher levels of spasticity. MAS is a reliable measurement with moderate to high interrater reliability and intrarater reliability.
Grip and pinch power
Time frame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
The electrical handgrip dynamometers (Jamar® Plus+ Hand Evaluation Kit) is used to assess the strength of hand grasp and lateral pinch (thumb and index) of both hands (distal part of UE). In each time of assessment, the patient grasp the handles in elbow flexion 90° and forearm in neutral position, and then make a maximum but stable power for about 5 seconds. Lateral pinch is assessed in a similar means. Each hand is assessed for three times in turns. Good accuracy (± 1-3%) and good reliability (inter-rater reliability and test-retest reliability) have been demonstrated.
Medical Research Council scale, MRC
Time frame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
The Medical Research Council scale (MRC) is used to assess muscle strength of the paretic UE. Eight muscle groups (including shoulder flexors, shoulder abductors, elbow flexors, elbow extensors, wrist flexors, wrist extensors, finger MP flexors, and finger MP extensors) is manually tested by the assessor. It is rated in a 6-point ordinal scale, and a higher score indicates stronger muscle. MRC has very good inter-rater reliability and intra-rater reliability.
Wolf Motor Function Test, WMFT
Time frame: Frame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
The Wolf Motor Function Test (WMFT) is a time-based test that measures UE movements and movement speed during functional tasks. The test includes 15 function-based tasks and 2 strength-based tasks. WMFT has standard template printed on the table to assure the placement of test objects, and the positions of patients in each task are also standardized. The participant is asked to perform the tasks with the affected UE as independently as possible, and as quickly as possible. Two types of scores are recorded during the task: WMFT-TIME (completing time of the task) and WMFT-FAS (functional abilities of the paretic UE). The maximum score of WMFT-TIME is 120 seconds, and a higher score means a slower movement. WMFT-FAS is scored from 0 to 5, and a higher score means a higher level of functional performance, better quality, coordination or precision of paretic UE during the task. WMFT has high interrater reliability, internal consistency, and test-retest reliability.
Nine-hole pegboard test, NPT
Time frame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
The Nine-hole pegboard test is used to measure finger dexterity of both UE. The participant is asked to take the pegs from a container (one by one), and place them into the holes on the board. After placing the pegs into nine holes, the participant needs to remove the pegs from the holes back into the container (one by one). All the process needs to be as quickly as possible. The NPT has very good interrater reliability and moderate to high test-retest reliability.
User experience
Time frame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
To understand the experience of using the robot-assisted therapy, a semi-structured interview is conducted to understand the patient's perspective. The interview takes about 10 minutes, recording and verbatim is used for further analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
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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.
Ching-yi Wu, ScD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amadeo-assisted training-1, Amadeo-assisted training-2 and Amadeo-assisted training-3 in people with Stroke, run by Chang Gung Memorial 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 6 inclusion and 6 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 17 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-Yi Wu, ScD (886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment, FMA (time frame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2021.