NCT00646347

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 5, 2009

Status Verified

February 1, 2009

Enrollment Period

10 months

First QC Date

March 24, 2008

Last Update Submit

February 4, 2009

Conditions

Paralytic Stroke

Keywords

strokeupper limb rehabilitationtreatmentmovement recovery from sever paralytic upper limbneuro hand orthosisself practice programsubacute

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

A

EXPERIMENTAL

Conventional stroke upper limb rehabilitation is given

Other: Conventional upper limb stroke rehabilitation

B

ACTIVE COMPARATOR

Neuro Hand Orthosis Program is given

Device: Neuro Hand Orthosis Program (NHOP)

Interventions

Conventional upper limb stroke rehabilitationOTHER

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.

A
Neuro Hand Orthosis Program (NHOP)DEVICE

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; 1. 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. 2. 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".

B

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Luke's Hospital (Singapore)

Singapore, 2 Bukit Batok, Street11, 659674, Singapore

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gribson Yu Chun Chan, Master

    St Luke's Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gribson Yu Chun Chan, Master

CONTACT

65632281gribsonchan@slh.org.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2008

First Posted

March 28, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2009

Study Completion

July 1, 2010

Last Updated

February 5, 2009

Record last verified: 2009-02

Locations

SG(1)