Study of the Effect of Peripheral Somatosensory Stimulation on the Functionality of Patients With Cerebral Palsy and Reduced Mobility

Facultat de ciencies de la Salut Universitat Ramon Llull

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Other: Physical Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06951568

2025-04-09

Details and patient eligibility

About

Cerebral palsy (CP) is a permanent neurological disorder that affects movement and posture, caused by an injury to the developing brain. It may also be accompanied by cognitive, hearing, and speech impairments, as well as epilepsy. Although it is a condition that manifests in childhood, its effects persist throughout life, posing specific challenges in mobility and functionality during adulthood. Although physiotherapy is a key component in the rehabilitation of children with CP and helps adults manage pain and improve motor function, many adults with CP do not receive the treatment they need. Barriers such as financial difficulties, transportation issues, and the lack of physiotherapists specialized in CP affect both access to and the quality of care. Even when physiotherapy is provided, adults with CP are often less satisfied with the services compared to children.The aim of this study is to promote the recovery of motor function in adults with cerebral palsy through sensory stimulation of the lower limbs, as part of an intensive motor rehabilitation program. This program seeks to foster autonomy in movements and transfers, as well as active participation in daily life activities.

Full description

Objective: To evaluate the impact of peripheral somatosensory stimulation on motor function in adults with cerebral palsy.

Methods: Experimental, crossover, and randomized. Each participant will serve as their own control and will be assessed under both stimulation (experimental) and non-stimulation (control) conditions.The sample will be one of convenience and will consist of the voluntary participation of 20 adults diagnosed with cerebral palsy who have reduced mobility and are institutionalized at the residence of the Catalan Foundation for Cerebral Palsy (FCPC).The physical exercise program will last for 2 days per week over a period of 12 consecutive weeks, with prior agreement from the center's management and their participation in the study. The 20 participants will be divided into two groups of 10 people. The first group (Group A) will begin the intervention with both the physiotherapy protocol and somatosensory stimulation, while the second group (Group B) will start with the physiotherapy protocol only. At the midpoint of the intervention, in week 6, the groups will switch: Group A will then receive only the physiotherapy protocol, and Group B will begin receiving somatosensory stimulation alongside the physiotherapy protocol. Both groups will continue under these conditions until week 12, marking the end of the intervention.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Adults with a medical diagnosis of cerebral palsy
• Age: 18-50 years
• Reduced mobility classified as levels I, II, or III according to the GMFCS
• Ability to participate in functional assessments with the support of the clinical team
• Ability to understand informed consent or have a legal representative who can provide consent on their behalf

Exclusion Criteria

• Patients with cerebral palsy who have severe cognitive impairments that hinder understanding of instructions or participation in assessments
• Adults with cerebral palsy who present with medical conditions that may interfere with the intervention, such as severe cardiovascular disease or major neurological disorders
• Individuals with cerebral palsy who are participating in another intervention study during the same period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Group Intervention INITIAL

Experimental group

Description:

Group INITIAL will begin the intervention with both the physiotherapy protocol and somatosensory stimulation, At the midpoint of the intervention, in week 6, the groups will switch: Group INITIAL will then receive only the physiotherapy protocol. Both groups will continue under these conditions until week 12, which marks the end of the protocol.

Treatment:

Other: Physical Exercise Program

Group Intervention CROSSED

Active Comparator group

Description:

Group CROSSED will start with the physiotherapy protocol only. At the midpoint of the intervention, in week 6, the groups will switch: Group CROSSED will receive somatosensory stimulation alongside physiotherapy. Both groups will continue under these conditions until week 12, which marks the end of the protocol.

Treatment:

Other: Physical Exercise Program