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

February 4, 2009 updated by: St Luke's Hospital, Singapore

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
    • 2 Bukit Batok, Street11
      • Singapore, 2 Bukit Batok, Street11, Singapore, 659674
        • Recruiting
        • St Luke's Hospital (Singapore)
        • Contact:
        • Principal Investigator:
          • Gribson Chan Yu Chun, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Conventional stroke upper limb rehabilitation is given
Other: 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.
ACTIVE_COMPARATOR: B
Neuro Hand Orthosis Program is given
Device: 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Action Research Arm Test (ARAT)
Time Frame: week 4 , week 10 , 6 months and 12 months
week 4 , week 10 , 6 months and 12 months
Motricity Index
Time Frame: week 4 , week 10 , 6 months and 12 months
week 4 , week 10 , 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Motor Activity Log (MAL)
Time Frame: At admission, week 4 , week 10 , 6 months and 12 months
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
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
At admission, week 4 , week 10 , 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Luke's Hospital, Singapore

Collaborators

National Council Of Social Service, Singapore

Investigators

  • Principal Investigator: Gribson Yu Chun Chan, Master, St Luke's Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ANTICIPATED)

January 1, 2009

Study Completion (ANTICIPATED)

July 1, 2010

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (ESTIMATE)

March 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2009

Last Update Submitted That Met QC Criteria

February 4, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • slhdoc02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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