Back to resultsA Pilot Study of Neuro Hand Orthosis Program In Stroke Upper Limb Rehabilitation (NHOP)
Primary Purpose
Paralytic Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Conventional upper limb stroke rehabilitation
Neuro Hand Orthosis Program (NHOP)
Sponsored by
About this trial
This is an interventional treatment trial for Paralytic Stroke focused on measuring stroke, upper limb rehabilitation, treatment, movement recovery from sever paralytic upper limb, neuro hand orthosis, self practice program, subacute
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
Sites / Locations
- St Luke's Hospital (Singapore)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Conventional stroke upper limb rehabilitation is given
Neuro Hand Orthosis Program is given
Outcomes
Primary Outcome Measures
Action Research Arm Test (ARAT)
Motricity Index
Secondary Outcome Measures
Motor Activity Log (MAL)
Modified Ashworth Scale for grading Spasticity
Shoulder pain at admission
Full Information
NCT ID
NCT00646347
First Posted
March 24, 2008
Last Updated
February 4, 2009
Sponsor
St Luke's Hospital, Singapore
Collaborators
National Council Of Social Service, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT00646347
Brief Title
A Pilot Study of Neuro Hand Orthosis Program In Stroke Upper Limb Rehabilitation
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
St Luke's Hospital, Singapore
Collaborators
National Council Of Social Service, Singapore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paralytic Stroke
Keywords
stroke, upper limb rehabilitation, treatment, movement recovery from sever paralytic upper limb, neuro hand orthosis, self practice program, subacute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Conventional stroke upper limb rehabilitation is given
Arm Title
B
Arm Type
Active Comparator
Arm Description
Neuro Hand Orthosis Program is given
Intervention Type
Other
Intervention Name(s)
Conventional upper limb stroke rehabilitation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Neuro Hand Orthosis Program (NHOP)
Intervention Description
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".
Primary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Time Frame
week 4 , week 10 , 6 months and 12 months
Title
Motricity Index
Time Frame
week 4 , week 10 , 6 months and 12 months
Secondary Outcome Measure Information:
Title
Motor Activity Log (MAL)
Time Frame
At admission, week 4 , week 10 , 6 months and 12 months
Title
Modified Ashworth Scale for grading Spasticity
Time Frame
At admission, week 4 , week 10 , 6 months and 12 months
Title
Shoulder pain at admission
Time Frame
At admission, week 4 , week 10 , 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gribson Yu Chun Chan, Master
Phone
65632281
Ext
273
Email
gribsonchan@slh.org.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gribson Yu Chun Chan, Master
Organizational Affiliation
St Luke's Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Luke's Hospital (Singapore)
City
Singapore
State/Province
2 Bukit Batok, Street11
ZIP/Postal Code
659674
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gribson Chan Yu Chun, Master
Phone
689532281
Ext
237
Email
gribsonchan@slh.org.sg
First Name & Middle Initial & Last Name & Degree
Gribson Chan Yu Chun, Master
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Neuro Hand Orthosis Program In Stroke Upper Limb Rehabilitation
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