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

NCT06951568 | Recruiting

• 1 other identifier: 2025-04-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Rivermead Mobility Index (RMI)

  To evaluate the level of functional mobility, focusing on tasks such as turning over, walking, and climbing stairs. 0-5 points: severely limited mobility. 6-10 points: moderately limited mobility. 11-15 points: mildly limited or good functional mobility.

  On the third day after the start of the intervention, in week 6, and in week 12.

Secondary Outcomes (3)

• the Trunk Impairment Scale.

  On the third day after the start of the intervention, in week 6, and in week 12.

• number of repetitions

  On the third day after the start of the intervention, in week 6, and in week 12.

• The time taken to perform the movement

  On the third day after the start of the intervention, in week 6, and in week 12.

Study Arms (2)

Group Intervention INITIAL

EXPERIMENTAL

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.

Other: Physical Exercise Program

Group Intervention CROSSED

ACTIVE COMPARATOR

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.

Other: Physical Exercise Program

Interventions

Physical Exercise Program OTHER

The physiotherapy protocol has been developed using the GMFCS scale as a reference. Based on this assessment, each patient's level is determined according to their functional motor abilities, limitations, and use of assistive or mobility devices. Each protocol consists of a total of five exercises: two general exercises and three specific exercises focused on the phases of the corresponding transfer and on skills common to all transfers. Rest periods of 2 minutes and 30 seconds are provided between exercises to ensure adequate recovery and a safe progression. The somatosensory stimulation will consist of intermittent mechanical pressure applied to the skin over the neuromuscular motor points of the quadriceps and gastrocnemius muscles. T

Group Intervention CROSSED; Group Intervention INITIAL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Facultat de ciencies de la Salut Universitat Ramon Llull: lead
• Cerebral Palsy Association: collaborator

Study Sites (1)

Pedro Victor López Plaza

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Pedro V López Plaza, Director

CONTACT

932 53 32 56; pedrovictorlp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 30, 2025
• Study Start: May 2, 2025
• Primary Completion: July 2, 2025
• Study Completion: September 30, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

ES (1)