NCT03153254

Brief Summary

The purpose of this study is to investigate the usability of a new upper limb robot assisted therapy device in 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
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

March 6, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

March 6, 2017

Last Update Submit

August 20, 2018

Conditions

Stroke

Keywords

Upper extremityRehabilitationRobot assisted therapyRoboticsDevicesOrthosis

Outcome Measures

Primary Outcomes (1)

  • Investigate user experience by a self-composed questionnaire.

    Investigate user experience by a self-composed questionnaire with theorems where upon users have to score. Possible scores range from 1 (totally disagree) to 4 (totally agree).

    Up to 30 minutes at the last session

Secondary Outcomes (2)

  • Measure the rate of perceived exertion by the Borg scale.

    Up to 5 minutes at the last session

  • Investigate whether wearing the device improves functionality by the Action Research Arm Test (ARAT).

    Up to 5 weeks (at week 1, week 2 and week 5)

Study Arms (2)

Healthy persons

EXPERIMENTAL

Test upper limb robot assisted therapy device. During 1 session of 1/2 hour.

Device: Test upper limb robot assisted therapy device

Stroke patients

EXPERIMENTAL

Training with new upper limb robot assisted therapy device. During 2 to 5 sessions of 1/2 hour.

Device: Training with new upper limb robot assisted therapy device

Interventions

Test upper limb robot assisted therapy deviceDEVICE

During 1 session of 1/2 hour.

Also known as: active orthosis, exoskeleton
Healthy persons
Training with new upper limb robot assisted therapy deviceDEVICE

During 2 to 5 sessions of 1/2 hour.

Also known as: active orthosis, exoskeleton
Stroke patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons between 18 and 85 years old that can perform all sorts of daily activities with their upper limbs
  • Ability to sit on a chair with adequate trunk stability
  • Ability to follow verbal instructions
  • Ability to communicate verbally with the researchers

You may not qualify if:

  • Ever had a fracture in the upper limbs
  • Ever had a surgery in the upper limbs
  • Pain in the upper limbs obstructing the execution of daily activities with the upper limbs
  • Physical trauma in the two months preceding the research
  • Mental problems that make the execution of daily activities unreliable
  • (Chronic) subluxation of the shoulder joint
  • Secundary soft tissue problems which may complicate the research or make it impossible (e.g. shoulder impingement, musculoskeletal problems, sensory deficits)
  • Pregnancy
  • Pacemaker
  • Known allergies for one of the components of the ARTHE rehabilitation tool
  • Stroke patients:
  • Stroke patients, more than three months after onset
  • Aged between 18 and 85 years
  • None to moderate spasticity in the hemiplegic arm (Modified Ashworth Scale: 0-2)
  • Detectable voluntary muscle activity at elbow flexion and elbow extension of the hemiplegic arm (Medical research council score: 1-5)
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

RevArthe

Edegem, Antwerp, 2650, Belgium

RECRUITING

Thomas More - Mobilab

Geel, Antwerp, 2440, Belgium

COMPLETED

REVAlution

Herentals, Antwerp, 2200, Belgium

ACTIVE NOT RECRUITING

Revalidatie & MS Centrum

Overpelt, Antwerp, 3900, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Lieven De Maesschalck

    Thomas More Kempen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieven De Maesschalck

CONTACT

014/56 23 10lieven.demaesschalck@thomasmore.be

Romy Sels

CONTACT

014/56 23 10romy.sels@thomasmore.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Phase 1: Healthy persons Phase 2: Stroke patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Innovation Manager

Study Record Dates

First Submitted

March 6, 2017

First Posted

May 15, 2017

Study Start

September 15, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(4)