Loaded and Task Specific Training in Spastic Diaplegic CP to Improve Gait and Functional Mobility.

NCT07474818 | Not Yet Recruiting

• 2 other identifiers: DPT/ERB/34U1111-1335-7052
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral Palsy is a non-progressive condition caused by early brain injury that affects movement, posture, and muscle tone. Spastic diplegia mainly involves the lower limbs, leading to stiffness, weakness, and abnormal gait patterns. These impairments reduce functional independence and increase caregiver burden. Loaded Treadmill Training and Task Specific Training are two rehabilitation approaches used to improve strength and Gait function. This study compares their effectiveness in improving gait and functional mobility in children with spastic diplegic CP.

Conditions

Spastic Diplegia Cerebral Palsy

Keywords

Spastic Cerebral Palsy; Gait Training; Functional Mobility; Loaded Treadmill Training; Task Specific Training; Gross Motor Function

Outcome Measures

Primary Outcomes (4)

• Change in Gait Parameter: Cadence

  Cadence, defined as the step rate or rhythm of the walk, will be measured in steps per minute. This data will be collected and analyzed using the Jakcs Observational Gait Analysis, a 66-item clinical evaluation checklist designed to systematically observe, identify, and document abnormalities or deviations in patient walking patterns.

  Baseline and after 6 weeks

• Change in Gait Parameter: Velocity

  Walking velocity (speed) will be measured in meters per minute. This parameter will be assessed and documented using the abbreviated 66-item Jakcs Observational Gait Analysis checklist.

  Baseline and 6 weeks

• Change in Gait Parameter: Stride Length

  Stride length, which is the measurement of the forward distance covered during two successive points of contact made by the same foot, will be measured in meters. This will be recorded using the Jakcs Observational Gait Analysis tool.

  Baseline and after 6 weeks

• Change in Functional Mobility

  Functional mobility will be assessed using Dimension E (Walking, Running \& Jumping) of the Gross Motor Function Measure-88 (GMFM-88). The GMFM-88 is a standardized observational instrument designed to assess functional mobility in children with cerebral palsy. It has five dimensions. The items in Dimension E are scored, and the total is calculated by averaging these percentages, where a higher percentage indicates better functional mobility and independence.

  Baseline and after 6 weeks

Study Arms (2)

Loaded Treadmil Training + Conventional Therapy

EXPERIMENTAL

Participants in the intervention will receive Loaded Treadmill Training for 40 minutes, 3 times per week, for 6 weeks. The session consists of three bouts of treadmill training with two 5-minute breaks. The treadmill's walking speed will be increased gradually. Additionally, conventional therapy will be given for 40 minutes 3 times per week, for 6 weeks

Device: Loaded Treadmill Training

Task-Specific Training + Conventional Therapy

ACTIVE COMPARATOR

Participants in this arm will receive Task-Specific Training (TST) for 40 minutes per session, 3 times per week, for 6 weeks. The sessions will include a 5-minute warm-up, 30 minutes of functional activities (progressing in difficulty every two weeks), and a 5-minute cool-down. Additionally, participants will receive 40 minutes of Conventional Physical Therapy per session, 3 times per week for 6 weeks.

Other: Task specific Training

Interventions

Loaded Treadmill Training DEVICE

loaded treadmill training is a gait rehabilitation approach in which children walk on a treadmill while external loads (such as ankle weights) are applied to the lower limbs. The load is gradually increased to enhance muscle strength, motor learning, and walking performance. This intervention helps improve stride length, cadence, gait velocity, and overall functional mobility in children with spastic diplegic cerebral palsy.

Loaded Treadmil Training + Conventional Therapy

Task specific Training OTHER

Task-specific training is a rehabilitation approach based on repetitive practice of functional activities. Children perform tasks such as standing, walking, stepping, and balance activities in a structured therapy program. This approach aims to enhance coordination, strength, motor control, and functional mobility in children with spastic diplegic cerebral palsy.

Task-Specific Training + Conventional Therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Confirmed diagnosis of Spastic Diplegic Cerebral Palsy
• to 12 years
• Gross Motor Function Classification System Level I to III
• Stand independently or with support

You may not qualify if:

• Diagnosed with any type other then Spastic Diplegic
• Presence of Comorbidities
• Severe Cognitive and Communicative impairments
• Classified as Gross Motor Function Classification System Level IV and V

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (1)

Lahore University of Biological Applied Health Sciences

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegic; Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Najam Zia Zia ul Haq, Doctor of Physical therapy

  Lahore College of physical therapy

  PRINCIPAL INVESTIGATOR

• Laiba Nadeem Nadeem, Doctor of Physical Therapy

  Lahore College of Physical Therapy

  PRINCIPAL INVESTIGATOR

• Ayesha Fatima, Doctor of Physical Therapy

  Lahore College of physical therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Misha Zahid Zahid, Doctor of Physicall Therapy

CONTACT

03277866777; misha.zahid@ubas.edu.pk

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: Demonstrator Study chair

Model Details: Not Needed

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 16, 2026
• Study Start: April 1, 2026
• Primary Completion: April 23, 2026
• Study Completion: July 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)