NCT02274675

Brief Summary

A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1 stroke

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 31, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

October 21, 2014

Results QC Date

May 2, 2015

Last Update Submit

July 3, 2015

Conditions

Stroke

Keywords

StrokeRobot-assisted therapyRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Motor Impairment of Wrist and Forearm

    Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject. Procedure: The procedure is done according to the standard guideline of this assessment scale.

    Motor impairment of wrist and forearm at week 6

Secondary Outcomes (6)

  • Motor Function Assessment of Hand Movement

    Motor function of hand function at week 6

  • Spasticity Level of Wrist

    Spasticity level of wrist at week 6

  • Forearm's Active Range of Movement

    Active range of motion of forearm at week 6

  • Forearm's Passive Range of Motion

    Passive range of motion of forearm at week 6

  • Wrist's Passive Range of Motion

    Passive range of motion of wrist at week 6

  • +1 more secondary outcomes

Study Arms (1)

Robot group

EXPERIMENTAL

Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy

Device: Robot-assisted therapy for wrist and forearmOther: Standard rehabilitation therapy

Interventions

Robot-assisted therapy for wrist and forearmDEVICE

Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.

Also known as: CR2-Haptic Rehabilitation Robot
Robot group
Standard rehabilitation therapyOTHER

Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities

Robot group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sub-acute and chronic stroke patients
  • Able to rest comfortable in training set-up
  • Mini-Mental Status Examination (MMSE) Score (\>21)
  • Motor Assessment Scale (Balance sitting \>3)
  • Modified Ashworth Scale (Wrist \< 2)

You may not qualify if:

  • Contractures in affected upper extremity which inhibit movements being tested

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Stroke Association of Malaysia (NASAM)

Petaling Jaya, Kuala Lumpur, 46050, Malaysia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

The limitations of this study include the relatively small number of subjects in each group, the variation in severity level across subjects and also the lack of comparison groups to differentiate the improvement benefit from robot therapy.

Results Point of Contact

Title
Project Leader
Organization
Universiti Teknologi Malaysia
cfyeong@utm.my

Study Officials

  • Yeong C Fai, PhD

    Universiti Teknologi Malaysia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 24, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 31, 2015

Results First Posted

July 31, 2015

Record last verified: 2015-07

Locations

MY(1)