StrokePhase 1NCT02274675
A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training
A Phase 1 study testing Robot-assisted therapy for wrist and forearm and Standard rehabilitation therapy in people with Stroke, run by Universiti Teknologi Malaysia at 1 site in Malaysia.
Trial summary
A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-assisted therapy for wrist and forearm and Standard rehabilitation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sub-acute and chronic stroke patients
- Able to rest comfortable in training set-up
- Mini-Mental Status Examination (MMSE) Score (>21)
- Motor Assessment Scale (Balance sitting >3)
- Modified Ashworth Scale (Wrist < 2)
Who cannot join
- Contractures in affected upper extremity which inhibit movements being tested
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
National Stroke Association of Malaysia (NASAM)
Petaling Jaya, Kuala Lumpur, 46050
About this study
A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program.
Read the detailed description
The objective of this study is to clinically assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program, and investigate the acceptance from patients and therapists. Total of 7 patients will be recruited in this study, all the patients will receive 1.5 hours of standard therapy together with 0.5 hour of robot therapy every day. The robot therapy will be a 30 mins long session for 3 to 5 days per week over a period of six weeks. The study will include forearm pronation-supination and wrist flexion-extension training.
- Conditions
- Stroke
- Being tested
- Robot-assisted therapy for wrist and forearm, Standard rehabilitation therapy
- Keywords
- Stroke, Robot-assisted therapy, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted therapy for wrist and forearmDevice
Also called CR2-Haptic Rehabilitation Robot
Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapyOther
Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
| Study group | Role | What they receive |
|---|---|---|
| Robot group | Experimental | Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy Receives: Device: Robot-assisted therapy for wrist and forearm; Other: Standard rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Impairment of Wrist and Forearm
Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject.
Procedure: The procedure is done according to the standard guideline of this assessment scale.
Measured: Motor impairment of wrist and forearm at week 6
Secondary outcomes (6)
Motor Function Assessment of Hand Movement
Introduction: Motor function that are related to wrist and forearm are measured using the Motor Assessment Scale. The Motor Assessment Scale (MAS) is a performance-based scale that was developed as a means of assessing everyday motor function in patients with stroke. In MAS, task 1 and 3 in the hand movement sub-component assessment were accessed (MAS-Hand), as the two task is the most related component to the tested movement.
Score: The total or maximum scores is 2, and minimum scores is 0. In this scale, the higher the score indicates the better the condition of the subject. The score for a healthy person is 2.
Procedure: The procedure is done according to the standard guideline of this assessment scale.
Measured: Motor function of hand function at week 6
Spasticity Level of Wrist
Introduction: The spasticity level of wrist is measured by using Modified Ashworth Scale. It measures resistance during passive soft-tissue stretching. This measure will only measure the wrist component, as forearm component is not included in this scale.
Scoring: The total or maximum scores for the subscale is 4 and the minimum is 0 score. Higher scores indicates the higher the tone, lower score indicates less tone. 0 score indicates normal tone and no increase in tone, while 4 scores indicate affected part rigid in flexion or extension. All the scores will be summed.
Procedure: The measuring procedure starts by holding the elbow as straight as possible at forearm pronated. Then, the patient's wrist is moved from maximum possible flexion to maximum possible extension. The test is performed up tp maximum of 3 times to avoid the influence of the effect of stretch.
Measured: Spasticity level of wrist at week 6
Forearm's Active Range of Movement
Introduction: Forearm's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in pronation-supination by moving with their own effort.
Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The normalized AROM for normal forearm pronation-supination is about 157 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree will be 0.
Procedure: The forearm AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the subject will move their forearm to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software.
Measured: Active range of motion of forearm at week 6
Forearm's Passive Range of Motion
Introduction: Forearm's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in pronation-supination directed by a person manually.
Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition.The normalized forearm pronation-supination is about 169 angular degree, a person who is able to achieve or over this range is considered normal or in good condition in this study. The minimum angular degree is 0.
Procedure: The forearm PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the forearm will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and stored as report in its software.
Measured: Passive range of motion of forearm at week 6
Wrist's Passive Range of Motion
Introduction: Wrist's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in flexion-extension directed by a person manually.
Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized PROM for normal wrist flexion-extension is about 164 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0.
Procedure: The wrist PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the wrist will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and store as report in its software.
Measured: Passive range of motion of wrist at week 6
Wrist's Active Range of Motion
Introduction: Wrist's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in by moving with their own effort.
Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized AROM for normal wrist flexion-extension is about 144 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0.
Procedure: The wrist's AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the subject will move their wrist to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software.
Measured: Active range of motion of wrist at week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- National Stroke Association of Malaysia (NASAM), Collaborative Research in Engineering, Science and Technology Center (CREST), Ministry of Higher Education (Lab2Market)
- Responsible party
- Principal investigator, Dr.Yeong Che Fai, Universiti Teknologi Malaysia
- Investigators
- Yeong C Fai, PhD, Principal investigator, Universiti Teknologi Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274675
- Sponsor's protocol ID
- UTM-CR2-001
- Status last verified
- Jul 2015
- First submitted
- 21 Oct 2014
- Last updated
- 31 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training
- ClinicalTrials.gov ID
- NCT02274675
- Acronym / sponsor ID
- UTM-CR2-001
- Conditions
- Stroke
- Keywords
- Stroke, Robot-assisted therapy, Rehabilitation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Universiti Teknologi MalaysiaUniversity, hospital or other
- Collaborators
- National Stroke Association of Malaysia (NASAM), Collaborative Research in Engineering, Science and Technology Center (CREST), Ministry of Higher Education (Lab2Market)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Posted 31 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program.
Detailed description
The objective of this study is to clinically assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program, and investigate the acceptance from patients and therapists. Total of 7 patients will be recruited in this study, all the patients will receive 1.5 hours of standard therapy together with 0.5 hour of robot therapy every day. The robot therapy will be a 30 mins long session for 3 to 5 days per week over a period of six weeks. The study will include forearm pronation-supination and wrist flexion-extension training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot group | Experimental | Device: Robot-assisted therapy for wrist and forearm, Other: Standard rehabilitation therapyReceive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sub-acute and chronic stroke patients
- Able to rest comfortable in training set-up
- Mini-Mental Status Examination (MMSE) Score (>21)
- Motor Assessment Scale (Balance sitting >3)
- Modified Ashworth Scale (Wrist < 2)
Key exclusion criteria (1 listed)
- Contractures in affected upper extremity which inhibit movements being tested
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 |
|---|---|---|
| Robot-assisted therapy for wrist and forearmAlso: CR2-Haptic Rehabilitation RobotRobot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training. | Device | Robot group |
| Standard rehabilitation therapyStandard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities | Other | Robot group |
Primary outcome
Motor Impairment of Wrist and Forearm
Time frame: Motor impairment of wrist and forearm at week 6
Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject. Procedure: The procedure is done according to the standard guideline of this assessment scale.
6 secondary outcomes
Motor Function Assessment of Hand Movement
Time frame: Motor function of hand function at week 6
Spasticity Level of Wrist
Time frame: Spasticity level of wrist at week 6
Forearm's Active Range of Movement
Time frame: Active range of motion of forearm at week 6
Forearm's Passive Range of Motion
Time frame: Passive range of motion of forearm at week 6
Wrist's Passive Range of Motion
Time frame: Passive range of motion of wrist at week 6
Wrist's Active Range of Motion
Time frame: Active range of motion of wrist at week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yeong C Fai, PhD principal investigator
Universiti Teknologi Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Robot-assisted therapy for wrist and forearm and Standard rehabilitation therapy in people with Stroke, run by Universiti Teknologi Malaysia at 1 site in Malaysia.
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 5 inclusion and 1 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 31 Jul 2015. 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 Malaysia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Motor Impairment of Wrist and Forearm (time frame: Motor impairment of wrist and forearm at week 6). 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 31 Jul 2015.