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

Paralytic Stroke Clinical Trial

— NHOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00646347
• Other study ID #: slhdoc02
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2008
• Last updated: February 4, 2009
• Start date: March 2008
• Est. completion date: July 2010

Study information

• Verified date: February 2009
• Source: St Luke's Hospital, Singapore
• Contact: Gribson Yu Chun Chan, Master
• Phone: 65632281
• Email: gribsonchan[@]slh.org.sg
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 89 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Paralytic Stroke
• Stroke

Intervention

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.

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; 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".

Locations

Country	Name	City	State
Singapore	St Luke's Hospital (Singapore)	Singapore	2 Bukit Batok, Street11

Sponsors (2)

Lead Sponsor	Collaborator
St Luke's Hospital, Singapore	National Council Of Social Service, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm Test (ARAT)		week 4 , week 10 , 6 months and 12 months	No
Primary	Motricity Index		week 4 , week 10 , 6 months and 12 months	No
Secondary	Motor Activity Log (MAL)		At admission, week 4 , week 10 , 6 months and 12 months	Yes
Secondary	Modified Ashworth Scale for grading Spasticity		At admission, week 4 , week 10 , 6 months and 12 months	Yes
Secondary	Shoulder pain at admission		At admission, week 4 , week 10 , 6 months and 12 months	Yes