Loaded Gait Training on Gross Motor Function in Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Conventional physical therapy program; Other: Loaded gait training

• Registration Number: NCT06339099
• Lead Sponsor: Cairo University

Brief Summary

A randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy. Children were divided randomly into two equal groups. The control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training. Gross motor functions and knee extensor strength were measured.

Detailed Description

A randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy (CP).

52 children with bilateral spastic CP, aged 5 to 7 years, were divided randomly into two equal groups. The control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training 3 times per week for an hour for 3 months.

Gross motor functions were measured by the Gross Motor Function Measure Scale-88 (GMFM-88); standing and walking domains, while knee extensor strength was measured by a hand-held dynamometer.

Study Timeline

• Study Start: 2023-02-26
• Primary Completion: 2023-10-15
• Status Verified: 2024-03
• Study Completion: 2024-03-15
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-24
• Last Update Submitted: 2024-03-24
• Study First Posted: 2024-04-01
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Age: five to seven years old, classified as levels II and III on the GMFCS.
• Spasticity grade from 1+ to 2 based on the Modified Ashworth scale.
• Able to understand and follow verbal commands and instructions (with a score above 80 on the Stanford Binet Intelligence Scale).

Read More

Exclusion Criteria

• Genetic or metabolic disorders.
• Brain tumours.
• Musculoskeletal dysfunction that would interfere with our intervention (e.g. tightness of the posterior knee joint capsule that causes passive knee extension lag, or fixed contracture of the knee joint).
• Surgical intervention in the lower limbs within the preceding 12 months.
• Botulinum toxin injections in lower limb muscles within the last six months.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Conventional physical therapy program	The intervention group (n=26) received conventional physical therapy program and loaded gait training.
Intervention arm	Loaded gait training	The intervention group (n=26) received conventional physical therapy program and loaded gait training.
control arm	Conventional physical therapy program	The control group (n=26) received a conventional physical therapy program.

Primary Outcome Measures

Name	Time	Method
Gross motor function	1 year	Gross Motor Function Measure Scale-88 (GMFM-88); standing and walking domains.
knee extensor strength	1 year	Knee extensor strength was measured by a hand-held dynamometer.

Trial Locations

Locations (1)

Faculty of Physical Therapy, Cairo University; 🇪🇬 Giza, Cairo, Egypt