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

NCT ID: NCT00646347

Last Updated: 2009-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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

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Paralytic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Conventional stroke upper limb rehabilitation is given

Group Type EXPERIMENTAL

Conventional upper limb stroke rehabilitation

Intervention Type OTHER

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.

B

Neuro Hand Orthosis Program is given

Group Type ACTIVE_COMPARATOR

Neuro Hand Orthosis Program (NHOP)

Intervention Type 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;

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".

Interventions

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Conventional 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.

Intervention Type OTHER

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".

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Council Of Social Service, Singapore

OTHER

Sponsor Role collaborator

St Luke's Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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St Luke's Hosptial

Principal Investigators

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Gribson Yu Chun Chan, Master

Role: PRINCIPAL_INVESTIGATOR

St Luke's Hospital, Singapore

Locations

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St Luke's Hospital (Singapore)

Singapore, 2 Bukit Batok, Street11, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Gribson Yu Chun Chan, Master

Role: CONTACT

65632281 ext. 273

Facility Contacts

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Gribson Chan Yu Chun, Master

Role: primary

689532281 ext. 237

Other Identifiers

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slhdoc02

Identifier Type: -

Identifier Source: org_study_id

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