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

NCT04768192 | Unknown

• 1 other identifier: GIP-745
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (8)

• GMFM - T-pre

  Gross Motor Function Measures (GMFM) acquired before the beginning of the treatment. (Functional measure)

  The week before the beginning of the treatment

• 6mwt - T-pre

  Six minute walking test (6mwt) performed before the beginning of the treatment. (Functional measure)

  The week before the beginning of the treatment

• Ashowrth scale - T-pre

  Ashowrth scale acquired before the beginning of the treatment. (Functional measure)

  The week before the beginning of the treatment

• Tardieu scale - T-pre

  Tardieu scale acquired before the beginning of the treatment. (Functional measure)

  The week before the beginning of the treatment

• GMFM - T-post

  Gross Motor Function Measures (GMFM) acquired after the end of the treatment. (Functional measure)

  Within a week after the ent of the treatment

• 6mwt - T-post

  Six minute walking test (6mwt) performed after the end of the treatment. (Functional measure)

  Within a week after the ent of the treatment

• Ashowrth scale - T-post

  Ashowrth scale acquired performed after the end of the treatment. (Functional measure)

  Within a week after the ent of the treatment

• Tardieu scale - T-post

  Tardieu scale acquired performed after the end of the treatment. (Functional measure)

  Within a week after the ent of the treatment

Secondary Outcomes (8)

• WF - T-pre

  The week before the beginning of the treatment

• FF - T-pre

  The week before the beginning of the treatment

• FA - T-pre

  The week before the beginning of the treatment

• MD - T-pre

  The week before the beginning of the treatment

• WF - T-post

  Within a week after the end of the treatment

Study Arms (1)

Pediatric patients with acquired brain injury

Subjects with a acquired brain injury occurred in the last 10 months prior the beginning of the treatment

Procedure: Physical Rehabilitation without lokomat; Procedure: Physical Rehabilitation with Lokomat

Interventions

Physical Rehabilitation without lokomat PROCEDURE

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.

Also known as: Conventional physiotherapy

Pediatric patients with acquired brain injury

Physical Rehabilitation with Lokomat PROCEDURE

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.

Also known as: Lokomat

Pediatric patients with acquired brain injury

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes pediatric patients with acquired brain lesion occurred in the last 10 months prior the beginning of the treatment and showing deficit in the lower limbs movements due to the acquired lesion.

You may qualify if:

• acquired brain lesion occurred in the last 10 months prior the beginning of the treatment
• hemi or tetraparesis diagnosis following the brain lesion
• thigh-bone length \> 21 cm
• ability and willingness to follow instructions and communicate fear and pain

You may not qualify if:

• severe contractures, fractures, bone instability or osteoporosis of the lower limbs
• skin lesions in the lower limbs
• thromboembolic or cardiovascular pathologies
• aggression and self-aggressive behavior
• orthopedic surgery and/or botulinum toxin injection in the 6 months prior to enrollment
• cognitive and/or motor deficits prior to the injury
• contraindications to MRI examination

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• The National Research Council, Italy: collaborator

Study Sites (1)

Scientific Institute IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Denis Peruzzo, PhD

  Research Institute IRCCS Eugenio Medea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denis Peruzzo, PhD

CONTACT

+39031877939; denis.peruzzo@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 24, 2021
• Study Start: January 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)