Action Observation Therapy in Children With Spastic Diplegia

NCT07651111 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006208
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effect of live versus video action observation training (AOT) on balance and gait in children with spastic diplegia.

Conditions

Spastic Diplegia

Outcome Measures

Primary Outcomes (3)

• Overall Stability Index (OSI)

  It will be assessed using the Biodex Balance System. Participants will stand on a dynamic platform at stability level 5 for three 30-second trials. The Overall Stability Index (OSI) will be recorded as a measure of postural stability in all directions. Lower OSI values indicate better balance control and greater postural stability.

  3 months

• Anteroposterior Stability Index (APSI)

  It will be measured using the Biodex Balance System during dynamic balance testing. APSI reflects the participant's ability to maintain balance in the forward and backward directions. Lower APSI scores indicate improved anteroposterior postural control.

  3 months

• Mediolateral Stability Index (MLSI)

  It will be assessed using the Biodex Balance System. MLSI evaluates the participant's ability to control balance in the side-to-side direction during dynamic standing. Lower MLSI values indicate better mediolateral stability and balance performance.

  3 months

Secondary Outcomes (3)

• Hip Flexion Angle

  3 months

• Knee Flexion Angle

  3 months

• Ankle Dorsiflexion Angle

  3 months

Study Arms (3)

A selected physical therapy program

ACTIVE COMPARATOR

Fifteen children will receive one hour of a selected physical therapy program, three times per week for 3 months.

Other: A selected physical therapy program

A selected physical therapy program + Live action observation training (AOT)

EXPERIMENTAL

Fifteen children will receive 30 minutes of the same selected physical therapy program plus 30 minutes of live AOT, three times per week for 3 months.

Other: A selected physical therapy program; Other: Live action observation training (AOT)

A selected physical therapy program + Video action observation training (AOT)

EXPERIMENTAL

Fifteen children will receive 30 minutes of the same selected physical therapy program plus 30 minutes of video AOT, three times per week for 3 months.

Other: A selected physical therapy program; Other: Video action observation training (AOT)

Interventions

Video action observation training (AOT) OTHER

Participants will receive video-based AOT for 30 minutes, 3 times per week, for 3 months. They will observe task demonstrations presented on a computer screen from multiple viewing angles, followed by guided practice and task performance, similar to the live AOT protocol.

A selected physical therapy program + Video action observation training (AOT)

Live action observation training (AOT) OTHER

Participants will receive live AOT for 30 minutes, 3 times per week, for 3 months. Each task will involve 3 minutes of observing the therapist performing the activity, followed by 3 minutes of verbal guidance and 3 minutes of task execution by the child. A 1-minute rest period will be provided between tasks.

A selected physical therapy program + Live action observation training (AOT)

A selected physical therapy program OTHER

Participants will receive a conventional physical therapy program, 3 sessions per week for 3 months. The program will include approximation exercises, balance training, functional activities (sit-to-stand, squatting, stair climbing), gait training with obstacles, walking exercises on different surfaces, and stretching exercises for the upper and lower limbs. The intervention aims to improve balance, mobility, coordination, and functional performance.

A selected physical therapy program; A selected physical therapy program + Live action observation training (AOT); A selected physical therapy program + Video action observation training (AOT)

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of diplegia who walk by a crouch gait.
• The age of the selected children will range from 4 to 7 years old.
• Degree of spasticity will range from 1 to 1+, according to modified Ashworth scale (MAS).
• They will be selected as Level II according to Gross motor function classification system (GMFCS).
• They will be able to understand the tasks and researchers' instructions.
• Their heights are not less than 1 meter to be able to see the screen of the Biodex balance system.

You may not qualify if:

• Visual or auditory impairments.
• Vestibular impairments.
• Fixed deformities of the upper, lower limbs, and the spine.
• Botulinum toxin (Botox) injection for the last six months.
• Orthopedic surgeries in the last six months.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic of the Faculty of physical therapy, Cairo University

Giza, 12511, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Eman Ibrahem El-Hadidy, PhD

  Professor, Cairo university

  STUDY CHAIR

• Mai Elsayed Abbass, PhD

  Ass. Professor, Cairo university

  STUDY DIRECTOR

Central Study Contacts

Esraa Elsayed Ali Elkiky, M.Sc

CONTACT

+20 10 92002696; esraa.elkiky@gmail.com

Mai Elsayed Abbass, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant lecturer

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

EG (1)