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

NCT01723046 | Unknown

• 1 other identifier: IWT120278
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Upper extremity; Rehabilitation; Robot assisted therapy; Robotics; Devices; Orthosis; clinical outcome

Outcome Measures

Primary Outcomes (5)

• Fugl-Meyer test upper limb section

  Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery.

  Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks

• Medical research council score

  Muscle strength assessment

  Change from baseline Medical research council score at 8 weeks and 12 weeks

• Active range of motion of the elbow joint

  The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently

  Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks

• Passive range of motion of the elbow joint

  The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.

  Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks

• Modified Ashworth Scale

  Spasticity measurement

  Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks

Secondary Outcomes (4)

• ABILHAND questionnaire

  Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks

• Functional independence measure

  Change from baseline Functional independence measure score at 8 weeks and 12 weeks

• Stroke impact scale

  Change from baseline Stroke impact scale score at 8 weeks and 12 weeks

• Intrinsic motivation inventory

  Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks

Study Arms (2)

Training with the device

EXPERIMENTAL

Training with new upper limb robot assisted therapy device

Device: Training with new upper limb robot assisted therapy device

Control group

NO INTERVENTION

The control group is treated with conventional therapy.

Interventions

Training with new upper limb robot assisted therapy device DEVICE

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

Also known as: active orthosis, exoskeleton

Training with the device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are medically unstable
• Cognitive disorders impeding the intervention
• Visual disorders impeding the intervention
• Subluxation of the shoulder joint
• Pusher syndrome

Sponsors & Collaborators

• Thomas More Kempen: lead

Study Sites (1)

Thomas More Kempen

Geel, Antwepen, 2440, Belgium

Location

MeSH Terms

Conditions

Stroke

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Lore Van de Perre, MSc

  Thomas More Kempen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lore Van de Perre, MSc

CONTACT

+32 14 56 23 10; lore.van.de.perre@khk.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study principal investigator

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 7, 2012
• Study Start: February 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

BE (1)