NCT01117194

Brief Summary

The purpose is to study the effect of rehabilitation robot on shoulder training for stroke patients.

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
12

participants targeted

Target at below P25 for phase_1 stroke

Timeline
Completed

Started Jan 2010

Typical duration for phase_1 stroke

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

December 21, 2012

Status Verified

November 1, 2012

Enrollment Period

3.1 years

First QC Date

January 18, 2010

Last Update Submit

December 20, 2012

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

  • Barthel index,

    1 year

  • Modified Asworth Scale

    1 year

  • STREAM and PASS scales

    1 year

Secondary Outcomes (1)

  • shoulder range of motion, VAS

    1 year

Study Arms (2)

shoulder training, rehabilitation robot

EXPERIMENTAL
Device: Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)

control group

NO INTERVENTION

Interventions

Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)DEVICE

Use an intelligent robot to assist upper limb rehabilitation.

Also known as: self-developed robotic arm
shoulder training, rehabilitation robot

Eligibility Criteria

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

You may qualify if:

  • stroke (1-3 months)
  • Brunnstrom Stage II-III
  • single, unilateral

You may not qualify if:

  • aphasic
  • shoulder impairment
  • severe osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt. Physical Medicine and Rehabilitation, NTUH

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Wen-Shiang Chen, MD, PhD

    Dpt. Physical Medicine and Rehabilitation, NTUH Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Shiang Chen

CONTACT

+886-2-2123456wenshiang@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2010

First Posted

May 5, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

December 21, 2012

Record last verified: 2012-11

Locations

TW(1)