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

Not Applicable

• Conditions: Paralytic Stroke

• Registration Number: NCT00646347
• Lead Sponsor: St Luke's Hospital, Singapore

Brief 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.

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 Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Primary Completion: 2009-01
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-04
• Last Update Posted: 2009-02-05
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	week 4 , week 10 , 6 months and 12 months
Motricity Index	week 4 , week 10 , 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Modified Ashworth Scale for grading Spasticity	At admission, week 4 , week 10 , 6 months and 12 months
Shoulder pain at admission	At admission, week 4 , week 10 , 6 months and 12 months
Motor Activity Log (MAL)	At admission, week 4 , week 10 , 6 months and 12 months

Trial Locations

Locations (1)

St Luke's Hospital (Singapore); 🇸🇬 Singapore, 2 Bukit Batok, Street11, Singapore