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Completed

NCT Number: NCT07121426

Effects of LIFT on Gait and Balance in Spastic Diplegic Cerebral Palsy Children

The goal of this Randomized control trial was to evaluate the outcome of limb intensive functional training (LIFT) on gait and balance in spastic diplegic cerebral palsy children with age 3-7 years.

The main questions this study has answered were:

* To access the improvement in children's gait and balance by providing interventions in clinical setting/ standardized environment and then at home environment. This study will check does the improvement in capacity level also improve their performance level in spastic diplegic CP children after getting targeted, activity focused and therapeutic interventions. * Researcher will compare the effects of intervention on both groups. Control group will receive Conventional physical therapy and traditional gait training at clinical setting while Experimental group will receive LIFT and conventional physical therapy at home settings provided by their caregivers. Both group will receive intervention 5days/week for 20 consecutive weeks.

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Husna Albab

Lahore, Punjab Province, 54000, Pakistan

About this study

GMFCS level 3 and MAS level 2 children were eligible to participate in study and Gross Motor Functional Measure (GMFM-88) was used to access Motor Capacity. 10-meter walk test, timed up and go test and 30 sec chair rise tests was used to access Motor Performance.

Method and Procedures of the research were explained to the patients earlier to data collection. Any query was explicated on the spot.

Group A: The Control group received conventional physical therapy (Stretching followed by Strengthening program and traditional gait training) at clinical setting.63 Stretching muscles were hip flexors, hip adductors, hamstrings and calf and stretching applied for 30 sec with 30 sec rest for 3-5 times for each muscle group with in pain limit followed by strengthening exercise for week muscle which includes the strengthening of anti-gravity muscles of lower limb they are: Quadriceps, Gluteus maximus and soleus performed in 3 groups. Each group contain 10 rep for each week muscle group. Conventional Physical therapy applied 5 days/week for consecutive 20 weeks. They were also guided to perform activities at home but they're unbound to do the designed activities freely.

Group B: The experimental group received Lower limb intensive functional training (LIFT) at home environment and conventional physical therapy at clinical setting. LIFT was provided at home environment for 3 hours/day, 5days/week for 5 months.31 A log book was maintained and the goals and strategies were guided to child's parents. 3 hours' treatment was performed in intervals at different time of the day. LIFT helped child in motor learning, skill progression and resistance training to target the strength, proprioception and coordination impairments of the lower extremities.64 Motor learning was based on Strength domain (Cycling) and progression from smooth to rough surface. Balance and Coordination domain involves activities such as (ball kicking with alternate legs and Static standing) and progression was done by increasing accuracy and complexity. Proprioception domain (Vertical jumping, sit to stand and cursing) while knee-immobilizers applied if needed and progression number of repetitions and sets was increased over time. Skill progression was used to challenge the LIFT and make it intensive enough to obtain changes in motor skills and function. AFO's were required during therapy session if needed.

Caregiver were provided proper guidelines before implementing the treatment at home. 3 training sessions was given prior to treatment. A log book was also provided to get the structured record of the treatment. Further videos and mode of tele-rehabilitation was used for supervision and guidance throughout the study. Therapist closely monitored the activities by checking daily logs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children with Spastic diplegic CP with aged 3-7 years Children of both gender Children with MAS level-2 Children with GMFCS level-3 The ability of caregivers to provide one-on-one attention to the child during dailyactivities

Exclusion criteria

Visual problems preventing performance of interventions and testing tasks59 Any orthopedic or neuro-surgery done in last 1 year60 Children with any other neurological conditions61 Children with uncontrolled seizures62

Treatment and study plan

Lower limb Intensive Functional Training

Other

LIFT will help the child in motor learning, skill progression and resistance training to target the strength, proprioception and coordination impairments of the lower extremities. Motor learning will be based on Strength domain (Cycling) . Balance and Coordination domain involves activities such as (ball kicking with alternate legs and Static standing) Proprioception domain (Vertical jumping, sit to stand and cursing) while applying knee-immobilizers if needed.

Conventional physical therapy

Other

Stretching followed by Strengthening program and traditional gait training at clinical setting. Stretching muscles were hip flexors, hip adductors, hamstrings and calf and stretching applied for 30 sec with 30 sec rest for 3-5 times for each muscle group with in pain limit followed by strengthening exercise for week muscle which includes the strengthening of anti-gravity muscles of lower limb they are: Quadriceps, Gluteus maximus and soleus performed in 3 groups. Each group contain 10 rep for each week muscle group.

Primary outcomes

  1. Gross motor function measure

    Time frame: at baseline and after 20 weeks

    GMFM-88 version and clause C, D and E will be used in this study.

Secondary outcomes

  1. 10 Meter Walk Test (10mwt)

    Time frame: at baseline and after 20 weeks

    10 MWT accesses performance and used for measurement of walking speed over short duration in meter/sec. It is used to calculate the functional mobility and gait

  2. Timed Up and Go Test (Tug)

    Time frame: at baseline and after 20 weeks

    TUG test evaluates balance, anticipatory postural control, functional mobility and agility in ambulatory children with CP. TUG can be used for differentiation in performance with different types of CP and different levels of GMFCS

  3. 30-sec chair rise test

    Time frame: at baseline and after 20 weeks

    The 30-sec chair rise test is used to access leg strength and endurance. 30 sec CRT accessed either by a specific number of sit-ups done in 30 second (e.g.; 10 reps, 5 reps etc.) or total repetitions of sit-ups and down done in 30 sec periods

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

Effects of Lower Limb Intensive Functional Training on Gait and Balance in Spastic Diplegic Cerebral Palsy Children

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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