MedTrace Logo

Functional and MRI Evaluation of the Robot-assisted and Traditional Rehabilitation Programs on the Muscle

NCT04768192 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2021-02-24

No results posted yet for this study

Summary

Walk recovery is one of the goals of rehabilitation programs in patients with acquired brain injury.

Recent experiences have shown the effectiveness of rehabilitation programs including traditional physiotherapy in combination with robotic gait training systems (Lokomat).

In this context, MRI can be used to assess the treatment effects on the muscular tissue, providing useful clinical indications for the optimization of the rehabilitation programs on the basis of the damage extension and the muscle characteristics.

Conditions

Interventions

PROCEDURE

Physical Rehabilitation without lokomat

Conventional physiotherapy is performed in 10 weekly sessions (45 minutes each) over 4 weeks(total 40 sessions). Specific exercises are administered to improve gait, balance and functional abilities focusing on: strengthening the gluteus and quadriceps muscles stretching the hip flexor and hamstrings muscles increasing static balance increasing dynamic balance increasing functional abilities improving ground gait going up and down the stairs. Physiotherapists can choose from a list of 25 standard exercises, according to some constraints: 1. strengthening exercises had to involve all the lower limb joints (no segmental intervention) 2. during each session, at least 4 out of the 7 categories above had to be delivered 3. the impossibility to perform any of the categories above during any session had to be recorded in the patient's treatment diary. Physiotherapists of the treatments group discuss patients' diaries during weekly meetings.

PROCEDURE

Physical Rehabilitation with Lokomat

The rehabilitation protocol consists of 20 sessions of robotic training alternated with 20 sessions of conventional physiotherapy (CP). Each treatment is performed in 5 weekly sessions (45 minutes each) over 4 weeks. Robotic training aimed to recovery/improve walking capacity from the initial Gross Motor Function Classification System (GMFCS) level. It is performed using the Lokomat® (Hocoma AG, Volketswil, Switzerland) gait orthosis. Initial set ups includes 50% body weight unload, gait velocity adjusted on the patient individual capability (1.5 km/h on average) and 100% guidance force. Both weight unload and guidance force are gradually reduced across sessions according to patient recovery of muscle strength and allowing patients to work harden and move more freely. Children engagement, active participation and motivation were reinforced through frequent encouragement by therapists and performance feedback implemented in the exercise video-games.

Sponsors & Collaborators

  • The National Research Council, Italy

    collaborator OTHER_GOV

  • IRCCS Eugenio Medea

    lead OTHER

Principal Investigators

  • Denis Peruzzo, PhD · Research Institute IRCCS Eugenio Medea

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-11-30
Completion
2021-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04768192 on ClinicalTrials.gov