Support Versus Loaded Treadmill Training in Treatment of Children With Cerebral Palsy

NCT05819216 | Unknown DMC

• 1 other identifier: 45178
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Children often suffer from disorders that alter their walking functions, such as cerebral palsy. Task-oriented training is one of the recent interventions to improve gait in children with cerebral palsy (CP). Some studies have shown the effectiveness of Partial Body Weight Support Treadmill Training (PBWSTT) for children with cerebral palsy. Another study supports the effectiveness of Loaded Treadmill Training (LTT) by placing additional weight on the lower extremity. There is still inconsistency in the results of studies advising which weight support or weight addition is more appropriate to use in improving walking in children with cerebral palsy. Objectives: This study aims to investigate the effectiveness of PBWSTT in the treatment of children with CP. Furthermore, to compare the effectiveness of LTT with PBWSTT. Methods: Two groups of twenty-two children with spastic cerebral palsy will be involved. Ages 4 to 10 and Gross Motor Functional Classification System (GMFCS) I -III. PBWSTT includes a 45- minute treadmill training session with 30% weight support for group one and LTT by adding 60% weight to lower limb while treadmill training for the second group. Spatiotemporal parameters will be measure additional to balance and endurance functions. Statistical analysis: Independent t test will be used to detect between group differences and paired t test to detect before and after trial differences. Significance level less than 0.05 and confidence interval 95%. Study design: Randomized Clinical Trial (Parallel Arm Design).

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Gait kinematics analysis: 3 dimensional motion capture system

  The system to be employed is the VICON Gait Analysis System, which uses a group of ten cameras to record the motion of the lower limbs.

  Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.

Secondary Outcomes (4)

• Gross Motor Functional Measure-66

  Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.

• Biodex Balance System (BBS)

  Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.

• Biodex System 4 - Isokinetic Dynamometer

  Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.

• Functional Reach Test (FRT)

  Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.

Study Arms (2)

partial body weight support treadmill training group

EXPERIMENTAL

A set of 24 sessions of partial body weight support treadmill training involve administration of a motorized treadmill with an attached overhead unweighting system of 30% of each participant's body weight will be decreased. The treatment session lasts for 45 min (3 sessions/ week, for 8 weeks).

Device: Treadmill

loaded treadmill training group

EXPERIMENTAL

A set of 24 sessions of loaded treadmill training includes a motorized treadmill with an additional load (sand bags) attached to the child's lower extremities. A 60% mass lower limb weight will be added.

Device: Treadmill

Interventions

Treadmill DEVICE

Gait training on treadmill training

Also known as: Treadmill training

loaded treadmill training group; partial body weight support treadmill training group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 4 to 10.
• Children with CP.
• Diplegic or quadriplegic CP regardless of the tonal abnormality.
• Ambulant with or without assistive devices.
• GMFCS = II-III.
• Able to stand and hold.

You may not qualify if:

• Children with hemiplegic CP
• Non-ambulant children
• Children with comorbidities.
• Fixed contractures.
• Severely affected CP.
• Severe cognitive or communicative impairment.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, 34221, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Dr. Alaa Ibrahim, PhD

  Imam Abdulrahman Bin Fisal University

  STUDY DIRECTOR

Central Study Contacts

Abdulmajeed Alotaibi, M.Sc.

CONTACT

+966505795288; 2220700003@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. candidate

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 19, 2023
• Study Start: May 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)