Paralytic StrokeNHOPNCT00646347
A Pilot Study of Neuro Hand Orthosis Program In Stroke Upper Limb Rehabilitation
A study testing Conventional upper limb stroke rehabilitation and Neuro Hand Orthosis Program (NHOP) in people with Paralytic Stroke, run by St Luke's Hospital, Singapore at 1 site in Singapore.
Trial summary
The implementation of Neuro Hand Orthosis Upper Limb Program can significantly improve the severe stroke paralytic arm in subacute rehabilitation as compared with the use of conventional therapy. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Paralytic Stroke
- What is being tested?
- Conventional upper limb stroke rehabilitation and Neuro Hand Orthosis Program (NHOP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2008to Jul 2010
- 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 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post stroke between one week to three months and medically stable
- Right Hemiplegia with right hand dominant
- Able to stand with minimum assistance
- AMT score not lesser then 7/10
- Motricity Index Arm Score <36/100
Who cannot join
- Unable to commit to the Neuro Hand Orthosis Program (either as in or out patients) for 10 weeks according to the program regime or unable to follow the control group regime for 10 weeks
- Pre-existence shoulder or upper limb pain
- Pre-existence moderate or severe hand oedema
- Patients with terminal disease
- Resident of Institution (eg, Nursing home etc prior to admission)
- Pre-existing upper limb disability on affected arm
- Psychiatric problem
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
St Luke's Hospital (Singapore)
Singapore, 2 Bukit Batok, Street11, 659674
Gribson Chan Yu Chun, Master, 689532281 ext. 237, gribsonchan@slh.org.sg
Gribson Chan Yu Chun, Master
About this study
Official title: A Pilot Study of Neuro Hand Orthosis Program: A Promising Restorative Therapy Treatment for the Severe Paralytic Arm in Subacute Stroke Rehabilitation
The implementation of Neuro Hand Orthosis Upper Limb Program can significantly improve the severe stroke paralytic arm in subacute rehabilitation as compared with the use of conventional therapy.
Read the detailed description
The neuro hand orthosis is based on a design of dynamic hand orthosis for orthopaedic patients. We attempt to apply such an orthosis on stroke patients to aid in regaining movement from severe paralytic arm by helping the patients to support their wrist and finger in a functional position for grasping. The patient is then encouraged to produce voluntary movement from the severe paralytic arm to transport an object (ball) from place to place either in sitting or standing position.
Since intensive arm usage is associated with neuro reorganisation, we propose designing a program with the neuro hand to encourage usage of the paralysed hand and help overcome the barriers of poor motivation and lack of arm usage through self practice program.
- Conditions
- Paralytic Stroke
- Being tested
- Conventional upper limb stroke rehabilitation, Neuro Hand Orthosis Program (NHOP)
- Keywords
- stroke, upper limb rehabilitation, treatment, movement recovery from sever paralytic upper limb, neuro hand orthosis, self practice program, subacute
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional upper limb stroke rehabilitationOther
Patient will be given a ten weeks conventional upper limb therapy. 3 sessions will be provided weekly in the first 4 weeks and 2 therapy sessions will be provided weekly in the subsequent 6 weeks. Patients will receive half an hour of conventional therapy in each session.
Patient will be taught to carry out two and half hours conventional self practice exercise daily for a period of ten weeks.
Neuro Hand Orthosis Program (NHOP)Device
The NHO is based on a design of dynamic hand orthosis for orthopaedic patients after hand surgery. We use it to support CVA patient's wrist and finger to perform grasping to transport an object (ball) from place to place to achieve the follows;
- NHO can assist stroke patients to experience successful hand grasping with an object and produce voluntary movement from their paralytic arm. This successful experience will positively reinforce the patient to continue to use their paralytic arm and change the patient's behavior and perception in the arm usage.
- The NHO Program is able to engage patients to perform their exercises and activities by themselves independently with the effect of intensive therapy.
The intervention (NHOP) group will receive same treatment intensity as the control group but with a "Neuro Hand Orthosis".
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Conventional stroke upper limb rehabilitation is given Receives: Other: Conventional upper limb stroke rehabilitation |
| B | Active comparator | Neuro Hand Orthosis Program is given Receives: Device: Neuro Hand Orthosis Program (NHOP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
Measured: week 4 , week 10 , 6 months and 12 months
Motricity Index
Measured: week 4 , week 10 , 6 months and 12 months
Secondary outcomes (3)
Motor Activity Log (MAL)
Measured: At admission, week 4 , week 10 , 6 months and 12 months
Modified Ashworth Scale for grading Spasticity
Measured: At admission, week 4 , week 10 , 6 months and 12 months
Shoulder pain at admission
Measured: At admission, week 4 , week 10 , 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2009 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paralytic 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Luke's Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Council Of Social Service, Singapore
- Investigators
- Gribson Yu Chun Chan, Master, Principal investigator, St Luke's Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646347
- Sponsor's protocol ID
- slhdoc02
- Acronym
- NHOP
- Status last verified
- Feb 2009
- First submitted
- 24 Mar 2008
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Neuro Hand Orthosis Program: A Promising Restorative Therapy Treatment for the Severe Paralytic Arm in Subacute Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT00646347
- Acronym / sponsor ID
- NHOP / slhdoc02
- Conditions
- Paralytic Stroke
- Keywords
- stroke, upper limb rehabilitation, treatment, movement recovery from sever paralytic upper limb, neuro hand orthosis, self practice program, subacute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St Luke's Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Council Of Social Service, Singapore
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 28 Mar 2008 (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.
The implementation of Neuro Hand Orthosis Upper Limb Program can significantly improve the severe stroke paralytic arm in subacute rehabilitation as compared with the use of conventional therapy.
Detailed description
The neuro hand orthosis is based on a design of dynamic hand orthosis for orthopaedic patients. We attempt to apply such an orthosis on stroke patients to aid in regaining movement from severe paralytic arm by helping the patients to support their wrist and finger in a functional position for grasping. The patient is then encouraged to produce voluntary movement from the severe paralytic arm to transport an object (ball) from place to place either in sitting or standing position.
Since intensive arm usage is associated with neuro reorganisation, we propose designing a program with the neuro hand to encourage usage of the paralysed hand and help overcome the barriers of poor motivation and lack of arm usage through self practice program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Conventional upper limb stroke rehabilitationConventional stroke upper limb rehabilitation is given |
| B | Active comparator | Device: Neuro Hand Orthosis Program (NHOP)Neuro Hand Orthosis Program is given |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post stroke between one week to three months and medically stable
- Right Hemiplegia with right hand dominant
- Able to stand with minimum assistance
- AMT score not lesser then 7/10
- Motricity Index Arm Score <36/100
Key exclusion criteria (7 listed)
- Unable to commit to the Neuro Hand Orthosis Program (either as in or out patients) for 10 weeks according to the program regime or unable to follow the control group regime for 10 weeks
- Pre-existence shoulder or upper limb pain
- Pre-existence moderate or severe hand oedema
- Patients with terminal disease
- Resident of Institution (eg, Nursing home etc prior to admission)
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 |
|---|---|---|
| Conventional upper limb stroke rehabilitationPatient will be given a ten weeks conventional upper limb therapy. 3 sessions will be provided weekly in the first 4 weeks and 2 therapy sessions will be provided weekly in the subsequent 6 weeks. Patients will receive half an hour of conventional therapy in each session. Patient will be taught to carry out two and half hours conventional self practice exercise daily for a period of ten weeks. | Other | A |
| Neuro Hand Orthosis Program (NHOP)The NHO is based on a design of dynamic hand orthosis for orthopaedic patients after hand surgery. We use it to support CVA patient's wrist and finger to perform grasping to transport an object (ball) from place to place to achieve the follows; 1. NHO can assist stroke patients to experience successful hand grasping with an object and produce voluntary movement from their paralytic arm. This successful experience will positively reinforce the patient to continue to use their paralytic arm and change the patient's behavior and perception in the arm usage. 2. The NHO Program is able to engage patients to perform their exercises and activities by themselves independently with the effect of intensive therapy. The intervention (NHOP) group will receive same treatment intensity as the control group but with a "Neuro Hand Orthosis". | Device | B |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: week 4 , week 10 , 6 months and 12 months
Motricity Index
Time frame: week 4 , week 10 , 6 months and 12 months
3 secondary outcomes
Motor Activity Log (MAL)
Time frame: At admission, week 4 , week 10 , 6 months and 12 months
Modified Ashworth Scale for grading Spasticity
Time frame: At admission, week 4 , week 10 , 6 months and 12 months
Shoulder pain at admission
Time frame: At admission, week 4 , week 10 , 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
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.
Gribson Yu Chun Chan, Master principal investigator
St Luke's Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional upper limb stroke rehabilitation and Neuro Hand Orthosis Program (NHOP) in people with Paralytic Stroke, run by St Luke's Hospital, Singapore 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 5 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: status not confirmed, as of the sponsor's last update on 5 Feb 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gribson Yu Chun Chan, Master (65632281 ext. 273, gribsonchan@slh.org.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: week 4 , week 10 , 6 months and 12 months). The study lists 2 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 5 Feb 2009; AzTrials last refreshed its copy on 6 Nov 2026.