Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat

NCT05767268 | Completed

• 1 other identifier: GIP919
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The use of robotic technologies in rehabilitation is an increasingly widespread practice in the health sector: the Lokomat is a medical device intended for walking rehabilitation, consisting of an exoskeleton, a treadmill and a harness that supports the body weight and acts as a safety tool This technology is useful in the rehabilitation of pathologies such as prenatal stroke, brain injury, paraplegia, multiple sclerosis and other motor, orthopedic and neurological problems. During these treatments, the psychological / emotional component of the patient is not properly considered and the success of the treatment remains focused on the motor-rehabilitation level. The management of subjective-experiential aspects remains in the hand of clinical figures (primarily physiotherapists) who have no tools for objective assessment other than their sensitivity. However, considering the experience is fundamental for the success of the therapy: this happens especially in the pediatric field, where clinical results improve significantly when children start therapy with a relaxed and positive mental state. The aim of this project is to investigate the rehabilitation experience of patients who perform gait rehabilitation by menas of the Lokomat system, considering the relationship between physiological parameters and moods. Therefore, the main goal is to monitor the patient's psychophysical condition before, during and after the rehabilitation activity, during the different sessions. This will allow describing, with qualitative and quantitative data, the user experience of the patient who undergoes a therapeutic treatment with the Lokomat.

Conditions

Cerebral Palsy; Acquired Brain Injury; Hereditary Spastic Paraplegia

Outcome Measures

Primary Outcomes (6)

• Heart Rate Variability (HRV) session 2

  HRV is measured during the second session of Lokomat rehabilitation by means of the photoplethysmogram sensor (PPG) of Empatica E4 bracelet.

  three days

• Electrodermal activity (EDA) session 2

  EDA is meadured during the second session of Lokomat rehabilitation by means of the electrodermal activity sensor of Empatica E4 bracelet.

  three days

• Heart Rate Variability (HRV) session 8

  HRV is measured during the eighth session of Lokomat rehabilitation by means of the photoplethysmogram sensor (PPG) of Empatica E4 bracelet.

  two weeks

• Electrodermal activity (EDA) session 8

  EDA is meadured during the 8th session of Lokomat rehabilitation by means of the electrodermal activity sensor of Empatica E4 bracelet.

  two weeks

• Heart Rate Variability (HRV) session 14

  HRV is measured during the 14th session of Lokomat rehabilitation by means of the photoplethysmogram sensor (PPG) of Empatica E4 bracelet.

  three weeks

• Electrodermal activity (EDA) session 14

  EDA is meadured during the 14th session of Lokomat rehabilitation by means of the electrodermal activity sensor of Empatica E4 bracelet.

  three weeks

Secondary Outcomes (9)

• Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 2

  three days

• Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 2

  three days

• Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 2

  three days

• Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 8

  two weeks

• Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 8

  two weeks

Study Arms (1)

treated with Lokomat

Patients perform a rehabilitation treatment of 15 or 20 sessions with lokomat + 15 or 20 sessions of physiotherapy in 3 or 4 weeks as defined by the clinician. During two or three sessions they wear a wearable device Empatica E4 that measure their electrocardiographic (ECG) activity and electrodermal activity (EDA). They also have a baseline acquisition of these signals in their room at hospital.

Device: Lokomat

Interventions

Lokomat DEVICE

gait rehabilitation

treated with Lokomat

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients that need gait rehabilitation treatment according to their clinician

You may qualify if:

• \- patients that need gait rehabilitation treatment according to their clinician

You may not qualify if:

• subjects unable to understand and execute simple instructions;
• subjects with skin problems in the wrist area intended for the application of the Empatica bracelet.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS Medea

Bosisio Parini, Italy

Location

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries; Spastic Paraplegia, Hereditary

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Design

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

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: March 14, 2023
• Study Start: February 2, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)