Skip to content

Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia

A Randomized Controlled Study Investigating the Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04997044
Enrollment
42
Registered
2021-08-09
Start date
2020-10-20
Completion date
2022-06-30
Last updated
2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

standard orthotic management, Selective dorsal rhizotomy, Bilateral Cerebral Palsy, Functional balance, Energy Cost of Walking, Functional capacity, Selective voluntary motor control:

Brief summary

The management of cerebral palsy is complex and requires a multidisciplinary approach. Selective dorsal rhizotomy is a neurosurgical technique that aims to reduce spasticity in the lower limbs and improve motor function.

Detailed description

the current study is designed to assess the effectiveness of Selective dorsal rhizotomy on motor function in ambulant children with spastic diplegia. therefore, A convenient sample of ambulant children with spastic diplegia will be allocated to two groups of equal numbers (control and experimental)

Interventions

OTHERConcomitant physical rehabilitation

Children of this group will receive a regular exercise rehabilitation program including starching exercises, functional strength training and static and dynamic balance exercises.The program will be conducted by six licensed pediatric physical therapists for one hour/session, 3 times/week, and six successive months.

A custom-made articulating ankle foot orthosis was prescribed with a hinge at the level of the medial malleolus extends distally to the tip of the toes and proximally on the posterior surface of the leg to about 5 cm below the knee and secured straps. It is fabricated to permit free ankle dorsiflexion and lock the plantar flexion at 0 dorsiflexion. The splinting schedule started gradually for 2 h/day in the first month, 4 h/day in the second month to the entire wake-up time of the day.

The surgical procedures were tailored to each child according to preoperative assessment plan. All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5 that left the facet joints intact.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

* CP, spastic diplegia * 4-8 years of age * The ability to walk with or without assistive devices typically on Level II-III on Gross Motor Function Classification System * At least six months after the last Botulinum toxin A injection in the lower extremities * Average intelligent quotient according to medical records for active participation * Good trunk control with good antigravity strength of lower extremity on clinical examination. Exclusionary criteria * Ankle clonus; exaggerated deep tendon reflex in the legs * Babinski sign * Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months * Moderate to severe signs of dystonia, athetosis or ataxia.

Design outcomes

Primary

MeasureTime frameDescription
Functional Balanceafter 6 months and after 1 year (follow-up)The pediatric balance scale was used to assess the child's functional performance with total score is 56 and higher score representing a better performance.
Gross motor functionafter 6 months and after 1 year (follow-up)The gross motor function measure-88 is used to evaluate the motor function with total score is 100 and higher scores representing a better performance.

Secondary

MeasureTime frameDescription
Selective voluntary motor controlafter 6 months and after 1 year (follow-up)Selective motor control of lower extremity scale is used for assessment of motor control of the lower limb joints in children with spastic cerebral palsy with a maximum score of 20 points, 10 points for each limb.
Energy cost of walkingafter 6 months and after 1 year (follow-up)The energy expenditure index (beats/meter) can be calculated as; walking heart rate (beats/min) minus resting heart rate (beats/ min) on walking velocity (meters/min).
Functional capacityafter 6 months and after 1 year (follow-up)The six-minute walking test is used to assess walking capacity in children with and without disabilities.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026