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Completed

NCT Number: NCT06339099

Loaded Gait Training on Gross Motor Function in Cerebral Palsy

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.

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Key information

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Gross motor function

    Time frame: 1 year

    Gross Motor Function Measure Scale-88 (GMFM-88); standing and walking domains.

  2. knee extensor strength

    Time frame: 1 year

    Knee extensor strength was measured by a hand-held dynamometer.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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