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

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Concomitant physical rehabilitation

Standard Orthotic Management

selective dorsal rhizotomy

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring standard orthotic management, Selective dorsal rhizotomy, Bilateral Cerebral Palsy, Functional balance, Energy Cost of Walking, Functional capacity, Selective voluntary motor control:

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Amira Mahmoud Abd-elmonem

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control group

Experimental group

Arm Description

control group

selective dorsal rhizotomy group

Outcomes

Primary Outcome Measures

Functional Balance

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 function

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 Outcome Measures

Selective voluntary motor control

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 walking

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 capacity

The six-minute walking test is used to assess walking capacity in children with and without disabilities.

Full Information

NCT ID

NCT04997044

First Posted

August 4, 2021

Last Updated

December 6, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04997044

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

October 20, 2020 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Other

Arm Description

control group

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

selective dorsal rhizotomy group

Intervention Type

Other

Intervention Name(s)

Concomitant physical rehabilitation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard Orthotic Management

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

selective dorsal rhizotomy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Functional Balance

Description

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.

Time Frame