Gait Rehabilitation in Diplegic Children

NCT05294874 | Completed

• 1 other identifier: pediatrics
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Standing and walking serve an individual's basic need to move from place to place, and both are the most common activities that people do on a daily basis. Aim: to investigate the combined effect of botulinum toxin A (BoNT-A) injection and ankle weight on the gait of diplegic children who are using Ankle foot orthoses.

Conditions

Cerebral Palsy; Spastic Diplegia

Keywords

gait; diplegia; ankle weight; botox injection

Outcome Measures

Primary Outcomes (2)

• measurement of knee excursion during gait

  evaluation of knee flexion range of motion during gait using two dimension gait analysis.

  after 3 months of the treatment program.

• evaluation of spasticity: modified ashowrth scale scores

  hamstring and calf muscles evaluation of spasticity through passive movement .the score ranged from 0 ( nearly normal) to 5 (rigid in flexion or extension)

  after 3 months of the treatment program.

Secondary Outcomes (1)

• electromyography to asses spasticity in hamstring and calf muscles

  after 3 months of the treatment program.

Study Arms (3)

classical gait training

ACTIVE COMPARATOR

physical therapy exercises including classical gait training

Other: gait training

classical gait training using ankle weight

ACTIVE COMPARATOR

physical therapy exercises including classical gait training while using ankle weight

Other: gait training

gait training using ankle weight after botulinum toxin injection

EXPERIMENTAL

physical therapy exercises including classical gait training while using ankle weight and with BOTOX injection

Other: gait training

Interventions

gait training OTHER

walking forward, sideway and backward walking on balance board

Also known as: rehabilitation

classical gait training; classical gait training using ankle weight; gait training using ankle weight after botulinum toxin injection

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosed as spastic diplegia.
• They were able to follow simple verbal instructions.
• The use of Ankle Foot Orthoses.
• Spasticity grade of 1+ or 2 in both calf and hamstring muscles according to modified Ashworth's scale (MAS).
• level I or II on the Gross Motor Function Classification System (GMFCS).

You may not qualify if:

• fixed contractures or deformities in the lower limbs.
• surgical orthopedic intervention.
• Botulinum A injection or use of neuromuscular blockers in the previous 6 months before the start of study.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy,Cairo University

Cairo, Giza Governorate, 02, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nahla mohamed, phd

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer physical therapy

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 24, 2022
• Study Start: July 15, 2021
• Primary Completion: November 14, 2021
• Study Completion: November 25, 2021
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publication of the results
• Access Criteria: through contact the authors

Locations

EG (1)