Robot Asissted Training on Neurodevelopmental Alterations

NCT06645795 | Active Not Recruiting

• 1 other identifier: RAGT_NEUROVELOP
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized crossover clinical trial is to determine the effect of robot assisted gait training combined with physiotherapy on body composition and functional variables in a pediatric population with neurodevelopmental disorders.The main questions to answer are:

• Does this treatment improve body composition parameters?
• Does the treatment help maintaining functionality and without causing discomfort or pain? Participants will perform 2 weekly physiotherapy sessions for 8 weeks, then there will be 4 weeks of washout, afer which each patient will cross over to the other group for 8 more weeks.

Conditions

Neurodevelopmental Disorders; Cerebral Palsy

Keywords

cerebral palsy; neurodevelopmental disorders; robot assisted gait training; physical therapy; body composition; musculoeskeletal

Outcome Measures

Primary Outcomes (6)

• Body composition, fat %

  Measured by bioimpedanciometry (BIA): fat (%).

  Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).

• Body composition, fat in kg

  Measured by bioimpedanciometry (BIA): fat (kg)

  Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).

• Body composition, lean mass (kg)

  Measured by bioimpedanciometry (BIA): lean mass (kg), lean mass (%), total mass (%), dry lean weight (%), Body mass index, and resistance at 50 kHz measured in Ohms

  Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).

• Body composition, lean mass (%)

  Measured by bioimpedanciometry (BIA): lean mass (%).

  Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).

• Body composition, dry lean weight

  Measured by bioimpedanciometry (BIA): dry lean weight (%).

  Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).

• Bone mineral density.

  Measured by ultrasound densitometry.

  Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).

Secondary Outcomes (14)

• Functional and musculoeskeletal assessmement, clinical data.

  Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).

• Functional and musculoeskeletal assessmement, musculoskeletal history.

  Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).

• Functional and musculoeskeletal assessmement, disability assessment

  Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).

• Functional and musculoeskeletal assessmement, range of motion

  Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).

• Functional and musculoeskeletal assessmement, spasticity

  Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).

Other Outcomes (10)

• Parameters of the RAGT intervention, total time

  During RAGT intervention sessions (8 weeks).

• Parameters of the RAGT intervention, distance.

  During RAGT intervention sessions (8 weeks).

• Parameters of the RAGT intervention, walking speed

  During RAGT intervention sessions (8 weeks).

Study Arms (2)

robot assisted gait training plus conventional physical therapy

EXPERIMENTAL

Participants will complete 8 weeks of intervention of robot assisted gait training plus conventional physical therapy.

Combination Product: Robot assisted gait training plus conventional physical therapy

Conventional physical therapy

ACTIVE COMPARATOR

Participants will complete 8 weeks of conventional therapy.

Other: Conventional pjysical therapy

Interventions

Robot assisted gait training plus conventional physical therapy COMBINATION_PRODUCT

Participants will complete 8 weeks of intervention of robot assisted gait training with the ATLAS 2030 exoskeleton (Marsi Bionics) owned by the school which they attend to. They will have 2 weekly sessions (16 sessions in total) for 4 weeks. Each session will last up to 1 hour (depending on the child's tolerance) although a minimum of 30 minutes per session and a minimum of 12 sessions will be set in this time. The training mode will be automatic. In addition, they will continue to carry out the rest of their usual treatments.

robot assisted gait training plus conventional physical therapy

Conventional pjysical therapy OTHER

Participants will complete 8 weeks of conventional therapy, with 2 sessions per week (16 sessions total). During the conventional treatment period, participants will continue with the conventional physical therapy they have received thus far. The content of the usual care treatment does not specifically address gait training, but consists of elements addressing range of motion, tone reduction, balance, activities of daily living, etc. The conventional intervention may be different for each individual based on their needs (to represent usual care), however, participants will be advised not to change the intervention, type, and frequency during the study.

Conventional physical therapy

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediactric population with neurodevelopmental disorders who have been diagnosed with cerebral palsy.
• With a level IV or V of the GMFCS.
• Adapted to the school environment (\> 6 months).
• Unable to stand without support.
• Receiving conventional physiotherapy (\> 6 months).
• Receiving a standing program (standing duration at school: at least 45 minutes/day).
• With ankle orthosis.
• Meeting the specific criteria of the exoskeleton manufacturer (ATLAS 2030 Marsibionics https://www.marsibionics.com/): Weight less than 35 kg, Hip width less than 35 cm, Distance from the center of rotation of the hip to that of the knee between 24 and 33 cm, distance from the center of rotation of the knee to that of the ankle between 23 and 32 cm, the ankle can reach close to 90º with or without an orthosis, shoe size less than 33, hip and knee flexion less than or equal to 20º (even after having previously warmed up).

You may not qualify if:

• Severe spinal deformity.
• Severe hip dysplasia.
• Knee and hip flexion greater than 20º.
• Children treated surgically within the 1-year period prior to the evaluation date.
• Skin inflammation and open skin lesions around the trunk or limbs.
• Uncontrolled epilepsy: active epilepsy resistant to medication.
• Pacemaker, defibrillator or osteosynthesis material carriers.

Sponsors & Collaborators

• University of Valencia: lead
• Instituto de Investigacion Sanitaria La Fe: collaborator
• CEE Cruz Roja Valencia: collaborator

Study Sites (1)

University of Valencia

Valencia, València, 46010, Spain

Location

Related Publications (4)

• Engsberg JR, Ross SA, Collins DR. Increasing ankle strength to improve gait and function in children with cerebral palsy: a pilot study. Pediatr Phys Ther. 2006 Winter;18(4):266-75. doi: 10.1097/01.pep.0000233023.33383.2b.

  PMID: 17108800 BACKGROUND

• McCormick AM, Alazem H, Zaidi S, Barrowman NJ, Ward LM, McMillan HJ, Longmuir P, Larin M, Dalton K. A randomized, cross-over trial comparing the effect of innovative robotic gait training and functional clinical therapy in children with cerebral palsy; a protocol to test feasibility. Contemp Clin Trials. 2023 Apr;127:107086. doi: 10.1016/j.cct.2023.107086. Epub 2023 Jan 17.

  PMID: 36669727 BACKGROUND

• Peungsuwan P, Parasin P, Siritaratiwat W, Prasertnu J, Yamauchi J. Effects of Combined Exercise Training on Functional Performance in Children With Cerebral Palsy: A Randomized-Controlled Study. Pediatr Phys Ther. 2017 Jan;29(1):39-46. doi: 10.1097/PEP.0000000000000338.

  PMID: 27984466 BACKGROUND

• Zhao X, Chen M, Du S, Li H, Li X. Evaluation of stress and pain in young children with cerebral palsy during early developmental intervention programs: a descriptive study. Am J Phys Med Rehabil. 2015 Mar;94(3):169-75; quiz 176-9. doi: 10.1097/PHM.0000000000000252.

  PMID: 25500686 BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders; Cerebral Palsy

Condition Hierarchy (Ancestors)

Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ANNA ARNAL-GOMEZ, Dr.

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiotherapy

Model Details: Randomized crossover clinical trial.

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 17, 2024
• Study Start: October 17, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

ES (1)