MedDataX Logo

Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke

NCT ID: NCT01723046

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this pilot study is to investigate the clinical effects of a new upper limb robot assisted therapy device that is linked to a virtual therapy environment in patients with stroke.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.

In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Upper extremity Rehabilitation Robot assisted therapy Robotics Devices Orthosis clinical outcome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Training with the device

Training with new upper limb robot assisted therapy device

Group Type EXPERIMENTAL

Training with new upper limb robot assisted therapy device

Intervention Type DEVICE

During 8 weeks, 3 times a week, 1 hour therapy sessions with the device

Control group

The control group is treated with conventional therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Training with new upper limb robot assisted therapy device

During 8 weeks, 3 times a week, 1 hour therapy sessions with the device

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

active orthosis exoskeleton

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with stroke, more than three months post onset
* No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale)
* Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score)
* Able to sit on a chair with adequate trunk stability
* Able to follow verbal instructions
* Able to communicate verbal information to the researchers

Exclusion Criteria

* Patients who are medically unstable
* Cognitive disorders impeding the intervention
* Visual disorders impeding the intervention
* Subluxation of the shoulder joint
* Pusher syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thomas More Kempen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lore Van de Perre

Study principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lore Van de Perre, MSc

Role: PRINCIPAL_INVESTIGATOR

Thomas More Kempen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Thomas More Kempen

Geel, Antwepen, Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lore Van de Perre, MSc

Role: CONTACT

Phone: +32 14 56 23 10

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lore Van de Perre, MSc

Role: primary

Peter Karsmakers, PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IWT120278

Identifier Type: -

Identifier Source: org_study_id