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

Study Overview
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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.

Official Title
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A Pilot Study of Neuro Hand Orthosis Program: A Promising Restorative Therapy Treatment for the Severe Paralytic Arm in Subacute Stroke Rehabilitation

Conditions
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Paralytic Stroke

Intervention / Treatment
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* Other: Conventional upper limb stroke rehabilitation
* Device: Neuro Hand Orthosis Program (NHOP)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Conventional stroke upper limb rehabilitation is given | Other: Conventional upper limb stroke rehabilitation<br>* 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.<br>|
| Active Comparator: B<br>Neuro Hand Orthosis Program is given | Device: Neuro Hand Orthosis Program (NHOP)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, upper limb rehabilitation, treatment, movement recovery from sever paralytic upper limb, neuro hand orthosis, self practice program, subacute