Preclinical basic functionality testing of a new prototype lower limb exoskeleton during common locomotion tasks

Phase 1

• Conditions: I61; I63; I69.4; G82; R54; Intracerebral haemorrhage; Cerebral infarction; Sequelae of stroke, not specified as haemorrhage or infarction; Paraplegia and tetraplegia; Senility

• Registration Number: DRKS00012374
• Lead Sponsor: Zürcher Hochschule für Angewandte Wissenschaften

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-25
• Study Completion: 2019-02-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

body mass index: 20-28 kg/m2
Mini Mental State Examination score > 24
Signed informed consent
unilateral impariment (for patients)
for stroke patients: main diagnosis: chronic stroke (>6 months); FAC score 3-5
for incomplete spinal cord injury: main diagnosis_ incomplete spinal cord injury (>6 months); FAC score 3-5
for frailty: 2 positive criteria for frailty phenotype, FAC score 3-5

Exclusion Criteria

acute musculoskeletal, cardiopulmonary, neurological diseases
amputations
for patients: excessive spasticity, joint mobility restrictions in the lower limbs that interfere with daily locomotion, pain, inability to wear prototype lower limb exoskeleton

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is a written report on the basic functionality of the prototype lower limb exoskeleton. Basic functionality will be assessed using qualitative and quantitative questionnaires about functionality, usability, perceived exertion and local pressure that will be answered by the study participants.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are the differences in kinematics, kinetics and muscle actitivy of the lower extermities with and without the prototype