NCT Number: NCT06951568
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Barcelona, Spain
Location status: Recruiting
Ismael Ordoñez
SUB_INVESTIGATOR
Jessica Zamora
SUB_INVESTIGATOR
Lorenzo Escutia
SUB_INVESTIGATOR
Marta Cuadros
SUB_INVESTIGATOR
Pedro V López
CONTACT
Pedro Victor López Plaza
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: On the third day after the start of the intervention, in week 6, and in week 12.
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.
Time frame: On the third day after the start of the intervention, in week 6, and in week 12.
To analyze trunk postural control 0 points: complete absence of trunk control.
1-7 points: severely impaired trunk control.
8-15 points: moderately impaired trunk control.
16-23 points: good trunk control (mild impairment or normal function).
Time frame: On the third day after the start of the intervention, in week 6, and in week 12.
To evaluate the number of repetitions in the specific exercises of the protocol
Time frame: On the third day after the start of the intervention, in week 6, and in week 12.
time required for execution and the completeness of the performance.
Contact information is provided by the study sponsor or research team.
Facultat de ciencies de la Salut Universitat Ramon Llull
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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