Clinical trial NCT06339099: Loaded Gait Training on Gross Motor Function in Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Bilateral spastic CP,
Gross motor function
Knee extensor strength
Loaded gait training
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 52
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children were randomly assigned into two equal groups.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Gross motor function
timeFrame: 1 year
measure: knee extensor strength
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: Cairo
Study officials:
affiliation: Faculty of Physical Therapy, Cairo University, Egypt
name: Radwa S Abdul-Rahman, PhD
role: PRINCIPAL_INVESTIGATOR
References: