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

NCT ID: NCT05819216

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2023-10-31

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).

Detailed Description

Study design:

A randomized clinical trial (parallel arm design) will compare the pre- and post-intervention effects of Partial Body Weight Support Treadmill Training and Loaded Treadmill Training.

Participants:

A convenience sampling technique will be used to recruit the children with cerebral palsy aged between 4 and 10 years who had Gross Motor Functional Classification System (GMFCS) from I to III and who could stand and hold. Children will be recruited from the Children's Hospital, Taif, Saudi Arabia.

Interventions:

the pre-and post-intervention effects of Partial Body Weight Support Treadmill Training and Loaded Treadmill Training will be compared. All children will be randomly divided into two groups. Both groups will receive 45-minute treadmill training sessions for 8 weeks (3 sessions per week) with a total of 25 sessions.

First group: (Partial Body Weight Support Treadmill Training) Involve administration of conventional treatment sessions. Further, sessions of Partial Body Weight Support Treadmill Training will be given at the rehabilitation center, outpatient clinic. Partial Body Weight Support Treadmill Training involves a motorized treadmill with an attached 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). A gradual decrease in unweight percentage, that keep knee extended during the stance phase. All procedures will be with assistance and under the observation of a well-trained pediatric physical therapist with an adequate experience with treadmill settings.

Second group: (Loaded Treadmill Training) Will receive a loaded treadmill training in addition to the conventional treatment sessions. Loaded Treadmill Training includes a motorized treadmill with an additional load attached to the child's lower extremities. A 60% mass lower limb weight will be added gradually and upon the child's tolerance. These procedures will be introduced under the supervision of a pediatric physical therapist with experience with treadmill settings. Furthermore, both groups will get the same conventional therapy that includes a range of motion, neurodevelopmental approach, and impairment-based therapies such as stretching and strengthening exercises for 30 minutes three times per week for 8 weeks.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

partial body weight support treadmill training group

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).

Group Type: EXPERIMENTAL

Treadmill

Intervention Type: DEVICE

Gait training on treadmill training

loaded treadmill training group

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.

Group Type: EXPERIMENTAL

Treadmill

Intervention Type: DEVICE

Gait training on treadmill training

Interventions

Treadmill

Gait training on treadmill training

Intervention Type: DEVICE

Other Intervention Names

Treadmill training

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role: lead

Responsible Party

Abdulmajeed Nasser Alotaibi

Ph.D. candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Alaa Ibrahim, PhD

Role: STUDY_DIRECTOR

Imam Abdulrahman Bin Fisal University

Locations

Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, Saudi Arabia

Countries

Saudi Arabia

Central Contacts

Abdulmajeed Alotaibi, M.Sc.

Role: CONTACT

2220700003@iau.edu.sa

+966505795288

Facility Contacts

ABDULMAJEED ALOTAIBI, PhD

Role: primary

2220700003@iau.edu.sa

+966505795288

Other Identifiers

45178

Identifier Type: -

Identifier Source: org_study_id