Loaded Gait Training on Gross Motor Function in Cerebral Palsy

Enhancing Gross Motor Function and Knee Extensor Strength During Loaded Gait Training in Children with Bilateral Spastic Cerebral Palsy: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Conventional physical therapy program; Other: Loaded gait training

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Giza, Cairo, Egypt, 12613
      • Faculty of physical therapy, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control arm; The control group (n=26) received a conventional physical therapy program.	Other: Conventional physical therapy program; This program included active resisted strengthening exercises for pelvis girdle and lower limb muscles, stretching exercises of tight muscles of lower limbs; hip flexors, hamstrings and calf muscle, balance activities from standing and walking and gait training exercises.
Active Comparator: Intervention arm; The intervention group (n=26) received conventional physical therapy program and loaded gait training.	Other: Conventional physical therapy program; This program included active resisted strengthening exercises for pelvis girdle and lower limb muscles, stretching exercises of tight muscles of lower limbs; hip flexors, hamstrings and calf muscle, balance activities from standing and walking and gait training exercises.; Other: Loaded gait training; An extra weight was added around the distal legs during gait training in the intervention group. This weight began at 0.5 kg and was gradually increased every two weeks to a maximum of 2 kg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Radwa S Abdul-Rahman, PhD, Faculty of Physical Therapy, Cairo University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 24, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Gross motor function; Bilateral spastic CP,; Knee extensor strength; Loaded gait training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: P.T.REC/012/002489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No