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Action Observation Therapy in Children With Spastic Diplegia

ConditionSpastic Diplegia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-7
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • A selected physical therapy program

    Other intervention

    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.

  • Live action observation training (AOT)

    Other intervention

    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.

  • Video action observation training (AOT)

    Other intervention

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: A selected physical therapy programActive comparator 1 intervention
Group B: A selected physical therapy program + Live action observation training (AOT)Experimental treatment 2 interventions
Group C: A selected physical therapy program + Video action observation training (AOT)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 months
3

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.

Time frame
3 months

Secondary outcomes

1

Hip Flexion Angle

It will be assessed using Kinovea motion analysis software during gait. Reflective markers will be placed on anatomical landmarks, and participants will walk at a self-selected speed while being recorded with a high-definition camera. Hip flexion will be measured during the late swing phase, corresponding to peak hip flexion. Greater hip flexion angles toward normative values will indicate improved gait kinematics.

Time frame
3 months
2

Knee Flexion Angle

It will be evaluated using Kinovea software from recorded gait videos. Anatomical markers will be positioned on the greater trochanter, lateral femoral condyle, and lateral malleolus. Knee flexion will be measured during the terminal stance phase. Changes toward normal knee kinematics will be considered indicative of gait improvement.

Time frame
3 months
3

Ankle Dorsiflexion Angle

It will be measured using Kinovea software during gait analysis. Reflective markers placed on the lower limb and foot will be used to calculate ankle joint kinematics. Ankle dorsiflexion will be assessed at initial contact. Increased dorsiflexion toward normal gait values will indicate improved gait performance.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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