The evaluation of rehabilitation effects using exoskeleton EKSO GT in patients with multiple sclerosis

Not Applicable

Completed

• Conditions: multiple sclerosis; gait limitations; postural control; fatigue; Neurological - Multiple sclerosis; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12616001284459
• Lead Sponsor: niversity of Rzeszow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Participants with Multiple Sclerosis,
Expanded Disability Status Scale (EDSS) 5,5-6,0

Exclusion Criteria

Difference in lower limbs length bigger then 2 cm
Weight above 100 kg
Height lower then 150 cm or above 190 cm
History of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device
Joint contractures of the hip, knee, or ankle that might limit normal ROM during ambulation
Medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe osteoporosis, or severe spasticity)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in muscular strength assessed by isokinetic dynamometer during knee flexion-extension (Biodex System 4 Pro, Biodex Medical Systems Inc. USA)[Baseline, after 3 weeks (time without EKSO GT), after next 3 weeks (treatment with EKSO), follow up after next 6 weeks ];Changes in balance assessed by baropodometric platform (Zebris FDM-S, Zebris Medical GmbH, Germany). Stabilometric evaluation of quiet standing (eyes open/eyes closed), weight bearing during quiet standing[Baseline, after 3 weeks (time without EKSO GT), after next 3 weeks (treatment with EKSO), follow up after next 6 weeks ];Changes in gait speed assessed by timed 25-foot walk test (T25FWT)[Baseline, after 3 weeks (time without EKSO GT), after next 3 weeks (treatment with EKSO), follow up after next 6 weeks ]

Secondary Outcome Measures

Name	Time	Method
Changes in muscular strength assessed by isokinetic dynamometer during shoulders internal and external rotation (Biodex System 4 Pro, Biodex Medical Systems Inc. USA)[Baseline, after 3 weeks (time without EKSO GT), after next 3 weeks (treatment with EKSO), follow up after next 6 weeks ];Fatigue assessed by Fatigue Severity Scale (FSS)[Baseline, after 3 weeks (time without EKSO GT), after next 3 weeks (treatment with EKSO), follow up after next 6 weeks ]