Loaded Gait Training on Gross Motor Function in Cerebral Palsy

NCT ID: NCT06339099

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2024-08-30

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.

Conditions

Cerebral Palsy

Study Design

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

Study Groups

control arm

The control group (n=26) received a conventional physical therapy program.

Group Type: EXPERIMENTAL

Conventional physical therapy program

Intervention Type: OTHER

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.

Intervention arm

The intervention group (n=26) received conventional physical therapy program and loaded gait training.

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy program

Intervention Type: OTHER

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.

Loaded gait training

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amina Awad,PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Radwa S Abdul-Rahman, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Physical Therapy, Cairo University, Egypt

Locations

Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/002489

Identifier Type: -

Identifier Source: org_study_id