StrokeNCT02188628
Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke
A study testing H-Man and Additional Conventional Therapy in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore, and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors will require specialized rehabilitation. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- H-Man and Additional Conventional Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2014to 31 Mar 2018
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First ever clinical stroke (ischaemic or haemorrhagic) confirmed on brain imaging
- Duration post stroke: 3 months to 24 months
- Age 21 to 85 years
- Hemiplegic pattern of arm motor impairment with Shoulder abduction MRC motor power >/= 3/5 and elbow flexion MRC motor power >/= 3/5
- Affected upper limb Fugl Myer Motor Assessment (FMMA) scale 20-50
- And / or associated motor incoordination or motor ataxia
Who cannot join
- Non stroke related causes of arm motor impairment
- Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, heart failure, asthma, depression, end stage renal failure, terminal malignancy), life expectancy <6 months, unhealed fractures or severe arm pain (visual analogue scale VAS > 5/10, pregnancy
- Inability to tolerate sitting for 90 minutes.
- Local factors which preclude robotic interfacing or may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain VAS >5/10, active fractures or arthritis or fixed flexion contractures of shoulder, elbow, wrist or fingers incompatible with interface with the H-man robot.
- Severe sensory impairment of affected limb
- Severe visual impairment, hemispatial neglect or homonymous hemianopia
- Cognitive impairments or uncontrolled behaviour. (Folstein mini mental state exam MMSE <26/28)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Refinement and Clinical Evaluation of the H-Man: A Novel, Portable, Inexpensive Planar Robot for Arm Rehabilitation After Stroke
Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore, and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors will require specialized rehabilitation. In recent years, robot-aided therapy has been proposed as a means of complementing traditional therapy to alleviate the burden on therapists and on the healthcare system. For shoulder/elbow rehabilitation, dozens of robots have been proposed in the literature but only half a dozen have been commercialized and typically none are seen in local clinics, due to exceedingly high costs. A novel, compact, inexpensive robotic interface, named 'H-Man', was recently designed and developed at NTU for experiments in motor control neuroscience. The H-man can generate computer-controlled force fields to assist or resist a subject's motion and is potentially an optimal trade-off between clinical efficacy and robotic complexity. A first prototype of the H-Man is available at NTU.The primary aim of this proposed project is to assess to what extent the investigators H-Man is suitable for rehabilitation purposes using a feasibility pilot clinical trial design involving stroke survivors. The investigators believe that H-Man can be used for neuro-rehabilitation of stroke patients with hemiparetic weakness, motor incoordination and motor ataxia of the upper limbs.In close cooperation between clinicians at the TTSH and NTU engineers, a portable version of the H-Man will be developed which will be tested in a 12 subject Pilot study, refined and then used in a 44 subject Randomized Controlled Trial (RCT) study. At the same time, the feasibility of H-Man integration for a pared down home use model will be assessed in 4 subjects.
The investigators primary hypothesis is that sub-acute/chronic patients will exhibit clinically significant decreases of impairment when training with the H-Man combined with standard arm therapy on robot-measured scales and standardized clinical scales, at the level of elbow/shoulder after 18 sessions of training on the H-Man.
Read the detailed description
As above
- Conditions
- Stroke
- Being tested
- H-Man, Additional Conventional Therapy
- Keywords
- Motor recovery, robotics, stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-ManDevice
Also called No other names.
H-man is a portable end-effector planar upper limb robot.
Additional Conventional TherapyOther
Also called No other names
Repetitive goals based arm therapy
| Study group | Role | What they receive |
|---|---|---|
| H-Man | Experimental | H-Man is a novel, portable, inexpensive end-effector upper limb robot. Receives: Device: H-Man |
| Additional Conventional Therapy | Active comparator | Repetitive goals based arm therapy Receives: Other: Additional Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Fugl Meyer Assessment of Motor Recovery
As above
Measured: 0, 3, 6, 12 and 24 weeks after start of intervention
Secondary outcomes (1)
Change from Baseline in Action Research Arm Test
As above
Measured: 0, 3, 6, 12 and 24 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study start1 Jul 2014
- Primary completion31 Dec 2017
- Study completion31 Mar 2018
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- H-Man training + conventional therapy vs equal amount of conventional therapy 1:1 allocation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Principal investigator, Chua Sui Geok, Karen, Tan Tock Seng Hospital
- Investigators
- Chua SG Sui Geok, MBBS,FRCP, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188628
- Sponsor's protocol ID
- 2014/00122
- Other IDs
- 2014
- Status last verified
- Sep 2019
- First submitted
- 2 Jul 2014
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Budhota A, Chua KSG, Hussain A, Kager S, Cherpin A, Contu S, Vishwanath D, Kuah CWK, Ng CY, Yam LHL, Loh YJ, Rajeswaran DK, Xiang L, Burdet E, Campolo D. Robotic Assisted Upper Limb Training Post Stroke: A Randomized Control Trial Using Combinatory Approach Toward Reducing Workforce Demands. Front Neurol. 2021 Jun 2;12:622014. doi: 10.3389/fneur.2021.622014. eCollection 2021.
PubMed 34149587
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement and Clinical Evaluation of the H-Man: A Novel, Portable, Inexpensive Planar Robot for Arm Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT02188628
- Acronym / sponsor ID
- 2014/00122
- Conditions
- Stroke
- Keywords
- Motor recovery, robotics, stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 11 Jul 2014 (estimated)
- 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.
Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore, and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors will require specialized rehabilitation. In recent years, robot-aided therapy has been proposed as a means of complementing traditional therapy to alleviate the burden on therapists and on the healthcare system. For shoulder/elbow rehabilitation, dozens of robots have been proposed in the literature but only half a dozen have been commercialized and typically none are seen in local clinics, due to exceedingly high costs. A novel, compact, inexpensive robotic interface, named 'H-Man', was recently designed and developed at NTU for experiments in motor control neuroscience. The H-man can generate computer-controlled force fields to assist or resist a subject's motion and is potentially an optimal trade-off between clinical efficacy and robotic complexity. A first prototype of the H-Man is available at NTU.The primary aim of this proposed project is to assess to what extent the investigators H-Man is suitable for rehabilitation purposes using a feasibility pilot clinical trial design involving stroke survivors. The investigators believe that H-Man can be used for neuro-rehabilitation of stroke patients with hemiparetic weakness, motor incoordination and motor ataxia of the upper limbs.In close cooperation between clinicians at the TTSH and NTU engineers, a portable version of the H-Man will be developed which will be tested in a 12 subject Pilot study, refined and then used in a 44 subject Randomized Controlled Trial (RCT) study. At the same time, the feasibility of H-Man integration for a pared down home use model will be assessed in 4 subjects.
The investigators primary hypothesis is that sub-acute/chronic patients will exhibit clinically significant decreases of impairment when training with the H-Man combined with standard arm therapy on robot-measured scales and standardized clinical scales, at the level of elbow/shoulder after 18 sessions of training on the H-Man.
Detailed description
As above
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- H-Man training + conventional therapy vs equal amount of conventional therapy 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| H-Man | Experimental | Device: H-ManH-Man is a novel, portable, inexpensive end-effector upper limb robot. |
| Additional Conventional Therapy | Active comparator | Other: Additional Conventional TherapyRepetitive goals based arm therapy |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First ever clinical stroke (ischaemic or haemorrhagic) confirmed on brain imaging
- Duration post stroke: 3 months to 24 months
- Age 21 to 85 years
- Hemiplegic pattern of arm motor impairment with Shoulder abduction MRC motor power >/= 3/5 and elbow flexion MRC motor power >/= 3/5
- Affected upper limb Fugl Myer Motor Assessment (FMMA) scale 20-50
Key exclusion criteria (7 listed)
- Non stroke related causes of arm motor impairment
- Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, heart failure, asthma, depression, end stage renal failure, terminal malignancy), life expectancy <6 months, unhealed fractures or severe arm pain (visual analogue scale VAS > 5/10, pregnancy
- Inability to tolerate sitting for 90 minutes.
- Local factors which preclude robotic interfacing or may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain VAS >5/10, active fractures or arthritis or fixed flexion contractures of shoulder, elbow, wrist or fingers incompatible with interface with the H-man robot.
- Severe sensory impairment of affected limb
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 |
|---|---|---|
| H-ManAlso: No other names.H-man is a portable end-effector planar upper limb robot. | Device | H-Man |
| Additional Conventional TherapyAlso: No other namesRepetitive goals based arm therapy | Other | Additional Conventional Therapy |
Primary outcome
Change from Baseline in Fugl Meyer Assessment of Motor Recovery
Time frame: 0, 3, 6, 12 and 24 weeks after start of intervention
As above
1 secondary outcome
Change from Baseline in Action Research Arm Test
Time frame: 0, 3, 6, 12 and 24 weeks after start of intervention
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 12 Sep 2019.
- Derived from this study: PubMed 34149587Budhota A, Chua KSG, Hussain A, Kager S, Cherpin A, Contu S, Vishwanath D, Kuah CWK, Ng CY, Yam LHL, Loh YJ, Rajeswaran DK, Xiang L, Burdet E, Campolo D. Robotic Assisted Upper Limb Training Post Stroke: A Randomized Control Trial Using Combinatory Approach Toward Reducing Workforce Demands. Front Neurol. 2021 Jun 2;12:622014. doi: 10.3389/fneur.2021.622014. eCollection 2021.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Chua SG Sui Geok, MBBS,FRCP principal investigator
Tan Tock Seng 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 H-Man and Additional Conventional Therapy in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 7 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 12 Sep 2019. 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 Singapore. 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 from Baseline in Fugl Meyer Assessment of Motor Recovery (time frame: 0, 3, 6, 12 and 24 weeks after start of intervention). 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 NCT02188628, 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 12 Sep 2019.