Loaded Gait Training on Gross Motor Function in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06339099
• Other study ID #: P.T.REC/012/002489
• Status: Completed
• Phase: N/A
• Start date: February 26, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 15, 2024
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, Cairo University	Giza	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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