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Status unknownNCT00646347NHOPUpdated Feb 5, 2009

A Pilot Study of Neuro Hand Orthosis Program In Stroke Upper Limb Rehabilitation

An interventional study of Conventional upper limb stroke rehabilitation and Neuro Hand Orthosis Program (NHOP) in Paralytic Stroke, sponsored by St Luke's Hospital, Singapore. Status unknown at 1 site in Singapore. Open to participants aged 50 Years to 89 Years. Per ClinicalTrials.gov, last updated 2009-02-05.

Sponsored by St Luke's Hospital, Singapore · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years to 89 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Paralytic Stroke

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Keywords

  • stroke
  • upper limb rehabilitation
  • treatment
  • movement recovery from sever paralytic upper limb
  • neuro hand orthosis
  • self practice program
  • subacute
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

St Luke's Hospital, Singapore is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    A

    Conventional stroke upper limb rehabilitation is given

    Other: Conventional upper limb stroke rehabilitation

  • Active comparator
    B

    Neuro Hand Orthosis Program is given

    Device: Neuro Hand Orthosis Program (NHOP)

Interventions

  • OtherConventional upper limb stroke rehabilitation

    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.

  • DeviceNeuro 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".

06

What researchers measure

Primary outcomes

  1. Action Research Arm Test (ARAT)

    Time frame: week 4 , week 10 , 6 months and 12 months

  2. Motricity Index

    Time frame: week 4 , week 10 , 6 months and 12 months

Secondary outcomes

  1. Motor Activity Log (MAL)

    Time frame: At admission, week 4 , week 10 , 6 months and 12 months

  2. Modified Ashworth Scale for grading Spasticity

    Time frame: At admission, week 4 , week 10 , 6 months and 12 months

  3. Shoulder pain at admission

    Time frame: At admission, week 4 , week 10 , 6 months and 12 months

07

Study locations

1 of 1 sites recruiting
  • St Luke's Hospital (Singapore)
    Singapore, 2 Bukit Batok, Street11 659674, Singapore
    • Gribson Chan Yu Chun, Master · Contact · gribsonchan@slh.org.sg · 689532281
    • Gribson Chan Yu Chun, Master · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00646347
Lead sponsor
St Luke's Hospital, Singapore
Collaborators
National Council Of Social Service, Singapore
First posted
Mar 28, 2008
Start date
Mar 2008
Primary completion
Jan 2009 (estimated)
Completion
Jul 2010 (estimated)
Last update
Feb 5, 2009

Study contacts

Gribson Yu Chun Chan, Master
Contact
gribsonchan@slh.org.sg
65632281 ext. 273
Gribson Yu Chun Chan, Master
principal investigator · St Luke's Hospital, Singapore

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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