Loaded Gait Training on Gross Motor Function in Cerebral Palsy

NCT06339099 | Completed

• 1 other identifier: P.T.REC/012/002489
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Bilateral spastic CP,; Gross motor function; Knee extensor strength; Loaded gait training

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

control arm

EXPERIMENTAL

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

Other: Conventional physical therapy program

Intervention arm

ACTIVE COMPARATOR

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

Other: Conventional physical therapy program; Other: Loaded gait training

Interventions

Conventional physical therapy program 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; control arm

Loaded gait training 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

Intervention arm

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Radwa S Abdul-Rahman, PhD

  Faculty of Physical Therapy, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinding. Parents were also blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Children were randomly assigned into two equal groups.

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 1, 2024
• Study Start: April 2, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)