Robot-assisted Training of the Upper Limb in Persons With Multiple Sclerosis: an Randomized Controlled Trial

Multiple Sclerosis Clinical Trial

Official title:

Robot-assisted Training on the Upper Limb in Persons With MS: an RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02257606
• Other study ID #: CME2011/315
• Status: Completed
• Phase: N/A
• First received: October 2, 2014
• Last updated: July 2, 2015
• Start date: July 2011
• Est. completion date: September 2011

Study information

• Verified date: July 2015
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

With this randomised intervention study, the investigators want to investigate the training effect of an 8 week training regime, using a robot-assisted training system in persons with MS. Besides conventional therapy, study participants in the experimental group will train 3 times per week during 30 minutes, using the haptic master. Research questions focus on the effects of additional robot assisted training on range of motion, movement quality and clinical tests for the upper limb in persons with MS. Evaluation by means of questionnaires and clinical outcome measures occured at baseline, after 4 weeks, after 8 weeks and at 16 weeks of follow-

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Multiple Sclerosis (McDonald criteria), upper limb dysfunction due to muscle weakness (Motricity Index <80), age > 18 years

Exclusion Criteria:

• MS relapse or glucocorticosteroid treatment in the last month before the start of the study, upper limb paralysis (Motricity Index < 18), other sever limitations, influencing participation (cognitive, visual)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• I-TRAVLE training

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Hasselt University	Expertise Centre for digital Media, iMinds, Interreg, Rehabilitation & MS Centre Overpelt, tUL

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motricity index	Random motor activity	2.5 min (pre-post)	No
Primary	Fugl-Meyer	Assessment of recovery of motor function	30 min (pre-post)	No
Primary	Action Research arm test	Grasp, grip, pinch, gross movement	15-20 min (pre-post)	No
Primary	Motor Activity log	perceived activities of daily life	45 min (pre-post)	No
Primary	Jamar handgrip strength	Handgrip strength	2.5 min (pre-post)	No