Clinical trial NCT06951568: Study of the Effect of Peripheral Somatosensory Stimulation on the Functionality of Patients With Cerebral Palsy and Reduced Mobility
Official title: Study of the Effect of Peripheral Somatosensory Stimulation on the Functionality of Patients With Cerebral Palsy and Reduced Mobility
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Facultat de ciencies de la Salut Universitat Ramon Llull
Sponsor class: OTHER
Collaborators: name: Cerebral Palsy Association
First posted: 2025-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Rivermead Mobility Index (RMI)
timeFrame: On the third day after the start of the intervention, in week 6, and in week 12.
Secondary outcomes:
measure: the Trunk Impairment Scale.
timeFrame: On the third day after the start of the intervention, in week 6, and in week 12.
measure: number of repetitions
timeFrame: On the third day after the start of the intervention, in week 6, and in week 12.
measure: The time taken to perform the movement
timeFrame: On the third day after the start of the intervention, in week 6, and in week 12.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Pedro Victor López Plaza
Study officials:
References: