Impact of Somatosensory Intensive Intervention on Motor Performance in Children With Unilateral Cerebral Palsy

NCT ID: NCT04235088

Last Updated: 2021-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-05

Study Completion Date

2021-03-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to investigate the effectiveness of an intensive somatosensory intervention in the upper limb of children with hemiparesis regarding structure, function, activity and participation

Hypothesis:

Intensive somatosensory activity based intervention is effective in upper limb and hand ability in children with hemiparesis, specially regarding activity and participation

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Feasibility and longitudinal study with blinding of the evaluator and the person analyzing the data. The study have 4 procedures:

1. \- Assessment pre-intervention
2. \- Intervention: three weeks
3. \- Assessment post-intervention
4. \- Follow-up assessment (three months after intervention).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unilateral Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Somatosensory intensive intervention

Group Type EXPERIMENTAL

Somatosensory intensive intervention

Intervention Type OTHER

The intensive somato-sensory intervention will take place during 3 weeks, 5 days per week, for 2 hours per day (30 hours of practice). During the week-ends, some somato-sensory written activities will be explained and handed to each family (6 hours of practice) Therapy sessions will be carried out in groups and each child will have his or her own therapist in charge of his or her treatment along the whole intervention. A daily check-list, design for that purpose, will be used by the therapist in order to register the gradually increased complexity of the activities and individual progression. The principal investigator will supervise all the interventions in order to assure their uniformity, adjusting the somato-sensory training protocol to the individual needs of each subject.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Somatosensory intensive intervention

The intensive somato-sensory intervention will take place during 3 weeks, 5 days per week, for 2 hours per day (30 hours of practice). During the week-ends, some somato-sensory written activities will be explained and handed to each family (6 hours of practice) Therapy sessions will be carried out in groups and each child will have his or her own therapist in charge of his or her treatment along the whole intervention. A daily check-list, design for that purpose, will be used by the therapist in order to register the gradually increased complexity of the activities and individual progression. The principal investigator will supervise all the interventions in order to assure their uniformity, adjusting the somato-sensory training protocol to the individual needs of each subject.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of unilateral cerebral palsy
* Manual Ability Classification System (MACS): levels I, II y III.
* Gender: male and female
* Age: 6 to 15 years old

Exclusion Criteria

* Existence of a moderate or severe cognitive impairment, which could interfere with the comprehension of the tester cues
* Botulinum toxic infiltration 4 months before the date of the pre-intervention assessment or during intervention or during the 3 months after the final intervention
* To have suffered any injury such as fractures and/or contusions in the upper limb in the last 12 months
* Orthopedic intervention in the 6 months preceding the study or during the study
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad San Jorge

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

César Cuesta García

Role: STUDY_DIRECTOR

Occupational Thinks Research Group, Autónoma University (Madrid)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asociación para la Investigación en la Discapacidad Motriz (AIDIMO)

Zaragoza, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UCP Somatosensory intervention

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.