Myosuit-based Gait Training

NCT05485597 | Unknown DMC

• 1 other identifier: RZS_05_2022
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the safety and feasibility of over-ground training sessions with the Myosuit for the neurological inpatients of rehabilitation clinic Zihlschlacht with a gait disorder and their therapists. It will also examine the acceptability and motivation of patients and therapists to use the device for training in the clinical setting and at home or community level. Moreover, it will present first results of the training efficacy with the Myosuit in the inpatient setting on the mobility level of the International Classification of Function. The proposed trial is designed as an open-label, non-randomized interventional study

Conditions

Neurologic Gait Disorder

Keywords

Exosuit; Training; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Usability of the Myosuit during task specific training

  The usability will be measured with the System Usability Scale (SUS). The SUS questionnaire will be completed by the participants, as well as therapists and therapy assistants. The SUS is an easy, valid and reliable tool for measuring the usability of a device. It consists of a 10-item questionnaire about the usability of a device with five response options for respondents; from strongly agree to strongly disagree. A score above 68 can be considered above average and anything below 68 is below average.

  4 weeks

• Usability of the Myosuit during task specific training

  The usability will be measured with the Usefulness, Satisfaction, and Ease of use Questionnaire (USE). The USE questionnaire will be completed by the participants, as well as therapists and therapy assistants. The USE measures the subjective usability of a product or service. It is a 30-item questionnaire that examines four dimensions of usability: usability, ease of use, ease of learning, and satisfaction. a higher score indicates better usability.

  4 weeks

• Safety of the Myosuit during task specific training.

  The safety will be analyzed by the risk of falling (near falls, falls and adverse events (AE)) and the change in walking speed, step length and cadence while performing the 10 Meter Walk Test (10MWT) with versus without the Myosuit.

  4 weeks

Secondary Outcomes (6)

• Motivation of patients to use the Myosuit during and after their inpatient rehabilitation

  4 weeks

• Motivation of therapists to use the Myosuit as a facilitator for gait training.

  4 weeks

• Motivation of therapy assistants to use the Myosuit as a facilitator for gait training.

  4 weeks

• Efficacy of the four-week Myosuit-based gait training on mobility

  4 weeks

• Efficacy of the four-week Myosuit-based gait training on walking speed

  4 weeks

Study Arms (1)

Study Group: Neurological inpatients with Gait disorders

EXPERIMENTAL

The group participates in the study intervention (they will undergo the Myosuit-based gait training)

Device: Myosuit-based gait training

Interventions

Myosuit-based gait training DEVICE

In a period of four weeks participants will undergo eight individual task-specific overground gait training sessions with the Myosuit. The sessions will be started with a therapist, and if possible and as soon as possible, the patient will train with an assistant. During the therapy sessions, the patient will be asked to perform various task-specific exercises with the Myosuit, such as Sit-to-stand-, Balance- and walking exercises. Depending on the individual skill level of the participant, a higher level of difficulty in task-specific exercises can be performed. The training sessions are set to last 45 minutes. All training sessions will be accompanied by a certified (physio)therapist or trained assistant and a study investigator.

Study Group: Neurological inpatients with Gait disorders

Eligibility Criteria

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

You may qualify if:

• FAC score between 2 and 4
• Intact or mildly to moderately impaired cognition: Mini Mental State Examination (MMSE) score above 17 points
• Subject is at least 18 years old
• A height between 150 cm and 195 cm
• A weight between 45 to 110 kg

You may not qualify if:

• Specific neurological disorders such as Parkinson's disease and Multiple sclerosis
• Neurological patients without gait disorders
• Unstable cardiovascular and respiratory conditions
• Functional Reach Test \< 15.24 cm
• MWT not possible with the assistance of a person
• Major musculoskeletal conditions (e.g., rheumatoid arthritis), major limited lower extremity's range of motion, orthopedic problems and/or significant lower extremity joint pain that could affect the application of the Myosuit
• Significant lower limb contractures (knee flexion or hip flexion contracture of \>10°, Varus deformity \>10°, Valgus deformity \>10°) that could affect the application of the Myosuit
• Skin integrity (on surfaces that would contact the device)
• Significant osteoporosis (bone fragility) assessed by a medical doctor
• Pregnancy
• Incapacity to (safely) understand and/or follow instructions (e.g., aphasia, limited knowledge of German)
• Incapacity to understand formal consent
• Currently participating in other (internal) interventional studies

Sponsors & Collaborators

• Rehaklinik Zihlschlacht AG: lead

Study Sites (1)

Rehaklinik Zihlschlacht AG

Zihlschlacht-Sitterdorf, 8588, Switzerland

RECRUITING

Related Publications (5)

• Haufe FL, Kober AM, Schmidt K, Sancho-Puchades A, Duarte JE, Wolf P, Riener R. User-driven walking assistance: first experimental results using the MyoSuit. IEEE Int Conf Rehabil Robot. 2019 Jun;2019:944-949. doi: 10.1109/ICORR.2019.8779375.

  PMID: 31374751 RESULT

• Haufe FL, Schmidt K, Duarte JE, Wolf P, Riener R, Xiloyannis M. Activity-based training with the Myosuit: a safety and feasibility study across diverse gait disorders. J Neuroeng Rehabil. 2020 Oct 8;17(1):135. doi: 10.1186/s12984-020-00765-4.

  PMID: 33032627 RESULT

• Wright A, Stone K, Martinelli L, Fryer S, Smith G, Lambrick D, Stoner L, Jobson S, Faulkner J. Effect of combined home-based, overground robotic-assisted gait training and usual physiotherapy on clinical functional outcomes in people with chronic stroke: A randomized controlled trial. Clin Rehabil. 2021 Jun;35(6):882-893. doi: 10.1177/0269215520984133. Epub 2020 Dec 27.

  PMID: 33356519 RESULT

• Buesing C, Fisch G, O'Donnell M, Shahidi I, Thomas L, Mummidisetty CK, Williams KJ, Takahashi H, Rymer WZ, Jayaraman A. Effects of a wearable exoskeleton stride management assist system (SMA(R)) on spatiotemporal gait characteristics in individuals after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2015 Aug 20;12:69. doi: 10.1186/s12984-015-0062-0.

  PMID: 26289955 RESULT

• Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2017 May 10;5(5):CD006185. doi: 10.1002/14651858.CD006185.pub4.

  PMID: 28488268 RESULT

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liliana Paredes, Dr.

CONTACT

+41714243730; l.paredes@rehaklinik-zihlschlacht.ch

Carmel Tulen, Bsc.

CONTACT

+41714243782; c.tulen@rehaklinik-zihlschlacht.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed trial is designed as an open-label, non-randomized interventional study.

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 3, 2022
• Study Start: August 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)