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

Not Applicable

• Conditions: Stroke
• Interventions: Device: Training with new upper limb robot assisted therapy device

• Registration Number: NCT01723046
• Lead Sponsor: Thomas More Kempen

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-07
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11
• Study Start: 2013-02
• Primary Completion: 2014-07
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Training with the device	Training with new upper limb robot assisted therapy device	Training with new upper limb robot assisted therapy device

Primary Outcome Measures

Name	Time	Method
Active range of motion of the elbow joint	Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks	The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
Passive range of motion of the elbow joint	Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks	The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
Modified Ashworth Scale	Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks	Spasticity measurement
Fugl-Meyer test upper limb section	Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks	Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery.
Medical research council score	Change from baseline Medical research council score at 8 weeks and 12 weeks	Muscle strength assessment

Secondary Outcome Measures

Name	Time	Method
ABILHAND questionnaire	Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks	Questionnaire-based assessment of manual ability
Functional independence measure	Change from baseline Functional independence measure score at 8 weeks and 12 weeks	Assessment of physical and cognitive disability, focusing on the burden of care.
Stroke impact scale	Change from baseline Stroke impact scale score at 8 weeks and 12 weeks	Questionnaire evaluating how stroke has impacted the person's health and life.
Intrinsic motivation inventory	Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks	Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.

Trial Locations

Locations (1)

Thomas More Kempen; 🇧🇪 Geel, Antwepen, Belgium