Clinical trial NCT00646347: A Pilot Study of Neuro Hand Orthosis Program In Stroke Upper Limb Rehabilitation
Official title: A Pilot Study of Neuro Hand Orthosis Program: A Promising Restorative Therapy Treatment for the Severe Paralytic Arm in Subacute Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paralytic Stroke
Keywords: stroke
upper limb rehabilitation
treatment
movement recovery from sever paralytic upper limb
neuro hand orthosis
self practice program
subacute
Lead sponsor: St Luke's Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National Council Of Social Service, Singapore
First posted: 2008-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: week 4 , week 10 , 6 months and 12 months
measure: Motricity Index
timeFrame: week 4 , week 10 , 6 months and 12 months
Secondary outcomes:
measure: Motor Activity Log (MAL)
timeFrame: At admission, week 4 , week 10 , 6 months and 12 months
measure: Modified Ashworth Scale for grading Spasticity
timeFrame: At admission, week 4 , week 10 , 6 months and 12 months
measure: Shoulder pain at admission
timeFrame: At admission, week 4 , week 10 , 6 months and 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: St Luke's Hospital (Singapore)
state: 2 Bukit Batok, Street11
Study officials:
affiliation: St Luke's Hospital, Singapore
name: Gribson Yu Chun Chan, Master
role: PRINCIPAL_INVESTIGATOR
References: