Effect of I-TRAVLE Training on Arm Function in MS and Chronic Stroke Patients

NCT01918748 | Unknown DMC

• 1 other identifier: I-TRAVLE
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

Rationale: Approx. 80% of acute stroke patients suffer from acute hemiparesis. Stroke patients have not reached their full potential when they are discharged from hospital. It is proven that extra training opportunities lead to further improvement. To date, new training possibilities, such as robotic techniques for rehabilitation, virtual reality training systems and tele-rehabilitation are being developed to aid in the training of stroke patients. Objective: To obtain preliminary evidence on the efficacy of an individualised, intensive 6-week technology-assisted training regime, featuring a robotics-based self-adapting arm training system (I-TRAVLE) in a virtual context, focussed on improvement of arm function and arm skill performance in chronic stroke patients with low to moderate proximal (shoulder/arm) muscle strength. Study design: single arm prospective cohort study. Study population: 16 stroke patients in the chronic phase after their stroke, aged \>=18, diagnosed with a central paresis of the arm, having low to moderate proximal (shoulder and arm) muscle strength. Intervention (if applicable): Haptic feedback of the I-TRAVLE robot either supports or challenges the patient to perform movements of the arm, thereby training motor control and co-ordination of the affected arm. Also strength and endurance of arm muscle use may be trained. The I-TRAVLE based training will last 6 weeks. Each week participants will attend training sessions on 3 days, during which they will train 2x 30 minutes, interspaced by at least half an hour to avoid (general) fatigue and overuse. Main study parameters/endpoints: Baseline measurements will be performed 3x prior to the start of the intervention, each interspaced by 1 week to assess baseline stability or any fluctuations in baseline values. In these chronic stroke patients spontaneous improvement is not expected. Also measurements will be performed at 0 weeks and at 12 weeks post training. Primary outcome measures: Wolf Motor Function Test, ABILHAND, and Goal Attainment Scaling. Secondary outcome measures are: motricity index, plate tapping task, active range of motion, perceived strength and fatigue.

Conditions

Multiple Sclerosis; Paralytic Stroke

Outcome Measures

Primary Outcomes (1)

• change from baseline Wolf Motor Function Test at 8 weeks and 3 months.

  The Wolf Motor Function Test (WMFT) test contains 15 timed and 2 strength tasks (lifting the weighted limb and grip strength), ordered from simple to complex, administered sequentially to each upper extremity and controlling for patient positioning.

  Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up

Secondary Outcomes (4)

• change from baseline motricity index at 8 weeks and 3 months

  Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up

• change from baseline plate tapping tasks at 8 weeks and 3 months

  Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up

• change from baseline active Range of Motion at 8 weeks and 3 months

  Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up

• change from baseline perceived strength & fatigue at 8 weeks and 3 months

  Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up

Other Outcomes (2)

• change from baseline ABILHAND at 8 weeks and 3 months

  Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up

• change from baseline Manual Ability Measure at 8 weeks and 3 months

  Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up

Study Arms (1)

MS & chronic stroke patients

EXPERIMENTAL

Intervention: 8 weeks of I-TRAVLE based training of proximal arm function, using the haptic master. Each week participants will attend training sessions on 5 days per 2 weeks, during which they will train 2 times 30 minutes I-TRAVLE assisted therapy, of which 1x 30 minutes supervised self-training. The two times half an hour training sessions per day will be interspaced by at least half an hour to avoid (general) fatigue and overuse of the affected arm in the subjects.

Device: Haptic Master

Interventions

Haptic Master DEVICE

The Haptic Master (HM) is a haptic device controlled according to the principles of 'admittance control'. In admittance control 'force' applied to the system (i.e. the HM arm) is measured, while 'position' (of the HM arm) is the end result.

Also known as: MOOG, Nieuw Vennep

MS & chronic stroke patients

Eligibility Criteria

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

You may qualify if:

• Clinically diagnosed with a central paresis of the arm/hand at entry in the study, caused by a supratentorial stroke;
• Post-stroke time more than 6 months (i.e. chronic phase after stroke);
• Having completed their active clinical rehabilitation program
• Hemiparesis featuring a low to moderate proximal (shoulder and arm) muscle strength:
• Motricity Index shoulder/arm item: minimum score of 14 and maximum 25 (out of 33), corresponding to a maximum active shoulder abduction of up to 90 degrees without resistance; and/or a minimum active shoulder anteflexion of 30 degrees and a maximum active range of motion of 120 degrees shoulder joint anteflexion which can actively be maintained for 10 seconds;
• a fair cognitive level, i.e. being able to understand the questionnaires and measurement instructions;
• ability to read and understand Dutch.

You may not qualify if:

• Severe spasticity of the arm, i.e. Modified Ashworth Scale (MAS) score for the elbow and wrist flexors: each ≥ 3;
• Severe visual impairment and/or severe cognitive impairment which may interfere with the execution of the arm-hand tasks or the measurements;
• Severe neglect in the near extra personal space (38), established by the letter cancellation test (39) and Bell's test (quantitative evaluation, (40)) with a minimum omission score of 15% (Ferber, 2001);
• Broca aphasia, Wernicke aphasia, global aphasia: as determined by the Akense Afasie Test (AAT) (41);
• Severe apraxia as measured by the apraxia test of van Heugten (42);
• no informed consent.

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (2)

Revalidatie & MS Centrum Overpelt

Overpelt, Limburg, 3900, Belgium

RECRUITING

Adelante Zorggroep

Hoensbroek, 6430 AB, Netherlands

RECRUITING

Related Links

• Website on the Individualised Technology-supported Robot-assisted Learning Environment (I-TRAVLE) system

MeSH Terms

Conditions

Multiple Sclerosis; Stroke

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peter Feys, Doctor

  University Hasselt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Feys

CONTACT

peter.feys@uhasselt.be

Anneleen Maris

CONTACT

anneleen.maris@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 4, 2013
• First Posted: August 8, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 8, 2013

Record last verified: 2013-08

Locations

NL (1); BE (1)