Effects of Perturbation Therapy and Trunk Control Training

NCT ID: NCT06244095

Last Updated: 2024-06-13

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2024-02-05

Brief Summary

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

A postural perturbation refers to unexpected change in conditions that upsets the body's harmony and displaces its posture. These perturbations can be sensory in nature, such as vestibular perturbations resulting from electrical stimulation, visual perturbations caused by a moving room or graphical images, or somatosensory perturbations caused by muscle vibrations. The body's reactions to these sensory perturbations may be based on the perception of instability rather than actual imbalance. Trunk control plays a vital role in various aspects of daily life, including balance, walking, and overall functional abilities. Children with cerebral palsy (CP), who experience limitations in their ability to move, often expend more energy compared to their healthy peers.

Detailed Description

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

This study will be randomized clinical trial used to compare the effects of Perturbation and trunk control training in children with Cerebral Palsy. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Pre-assessment will be done using Berg balance scale, functional Independent measures and TUG test as objective measurements. Subjects in one group will be treated using Perturbation therapy and the other one will be treated with Trunk control training. Both groups had three treatment sessions per week, for 4 weeks, and the total time for every session was about 30-45 minutes. A postural perturbation refers to unexpected change in conditions that upsets the body's harmony and displaces its posture. These perturbations can be sensory in nature, such as vestibular perturbations resulting from electrical stimulation, visual perturbations caused by a moving room or graphical images, or somatosensory perturbations caused by muscle vibrations. The body's reactions to these sensory perturbations may be based on the perception of instability rather than actual imbalance. On the other hand, "mechanical perturbations" physically displace the body segments, potentially leading to a shift in the overall center of mass or actual imbalance. Even small displacements of a single body segment, like the head, can elicit minor muscle responses throughout the body

Conditions

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

Cerebral Palsy

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Perturbation Therapy

Perturbation Therapy will be given to this group.

Group Type EXPERIMENTAL

Perturbation Therapy

Intervention Type OTHER

The applicants were instructed to perform various exercises, including rotating their trunks, tossing a ball, and maintaining pelvis neutrality. They were also asked to reach the toy sideways with one hand. The 6-week intervention was conducted four days a week for 60 minutes each day, focusing on trunk rotation, standing, tossing, and catching the ball in various directions. The training sessions lasted for 20 minutes each.

Trunk Control Therapy

Trunk control activities will be given to this group.

Group Type ACTIVE_COMPARATOR

Trunk Control Therapy

Intervention Type OTHER

For the duration of each session, the manual pushes and pulls were administered around once per minute and lasted for 20 minutes. A platform that can be moved in four directions.Choosing to step and stroll when there is an outside disturbance. When routine motions such as sit-to-stand transitions, disruptions are applied when standing, walking, or other activities. Training with continuous disruptions simulates scenarios such as uneven terrain. Both rope and cable excursions are above ground and last for 20 minutes. Briefly explain the platform to the participants. Asked the participants to push the torso and waist against the wall during the session. Emerging barriers during training sessions like small obstacles (e.g. pair of bricks) then Lean the participants with the support of the therapist and let them go. Asked them to Step on a mushy or slick surface in session for 20 minutes. Each intervention session took place for 60 minutes per day four days of week for 6 weeks.

Interventions

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

Perturbation Therapy

The applicants were instructed to perform various exercises, including rotating their trunks, tossing a ball, and maintaining pelvis neutrality. They were also asked to reach the toy sideways with one hand. The 6-week intervention was conducted four days a week for 60 minutes each day, focusing on trunk rotation, standing, tossing, and catching the ball in various directions. The training sessions lasted for 20 minutes each.

Intervention Type OTHER

Trunk Control Therapy

For the duration of each session, the manual pushes and pulls were administered around once per minute and lasted for 20 minutes. A platform that can be moved in four directions.Choosing to step and stroll when there is an outside disturbance. When routine motions such as sit-to-stand transitions, disruptions are applied when standing, walking, or other activities. Training with continuous disruptions simulates scenarios such as uneven terrain. Both rope and cable excursions are above ground and last for 20 minutes. Briefly explain the platform to the participants. Asked the participants to push the torso and waist against the wall during the session. Emerging barriers during training sessions like small obstacles (e.g. pair of bricks) then Lean the participants with the support of the therapist and let them go. Asked them to Step on a mushy or slick surface in session for 20 minutes. Each intervention session took place for 60 minutes per day four days of week for 6 weeks.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Kids that suffer from cerebral palsy.
* Ages span from 5 to 10 years.
* Both males and females were represented.
* During the preceding half-year, there was no orthopedic surgery or spasticity-reduction intervention.
* No significant lower limb muscular contraction

Exclusion Criteria

* Individuals suffering from sensory, proprioceptive, cognitive, and perceptual impairments, as well as those with contractures.
* Any neurological disease that impairs balance, including orthopedic disorders
* Individual experiencing seizures and has undergone any prior surgical treatments.
* Uncorrected visual issues
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Riphah International University

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.

Zirwa Afzal, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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

Imran Amjad

Lahore, Punjab Province, Pakistan

Site Status

Countries

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

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

Horak FB, Earhart GM, Dietz V. Postural responses to combinations of head and body displacements: vestibular-somatosensory interactions. Exp Brain Res. 2001 Dec;141(3):410-4. doi: 10.1007/s00221-001-0915-6.

Reference Type BACKGROUND
PMID: 11715086 (View on PubMed)

Other Identifiers

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

REC/RCR&AHS/23/0737

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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