NCT07121426

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 18, 2023

Last Update Submit

August 8, 2025

Conditions

Keywords

Cerebral palsy, Balance, Gait, Spastic Diplegia

Outcome Measures

Primary Outcomes (1)

  • Gross motor function measure

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

    at baseline and after 20 weeks

Secondary Outcomes (3)

  • 10 Meter Walk Test (10mwt)

    at baseline and after 20 weeks

  • Timed Up and Go Test (Tug)

    at baseline and after 20 weeks

  • 30-sec chair rise test

    at baseline and after 20 weeks

Study Arms (2)

Control Group

EXPERIMENTAL

Control group will receive Conventional physical therapy and traditional gait training at clinical setting.

Other: Conventional physical therapy

Intervention Group

EXPERIMENTAL

Experimental group will receive LIFT and conventional physical therapy at home settings provided by their caregivers.

Other: Lower limb Intensive Functional TrainingOther: Conventional physical therapy

Interventions

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.

Intervention Group

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.

Control GroupIntervention Group

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Husna Albab

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • 1. Khumlee N, Suriyaamarit D, Boonyong S. Effects of sensory cues on dynamic trunk control in children with spastic diplegic cerebral palsy. Physiotherapy Theory and Practice 2021: 1-8. 2. Ma Y, Liang Y, Kang X, Shao M, Siemelink L, Zhang Y. Gait characteristics of children with spastic cerebral palsy during inclined treadmill walking under a virtual reality environment. Applied bionics and biomechanics 2019; 2019. 3. Zarkou A, Lee SC, Prosser LA, Jeka JJ. Foot and ankle somatosensory deficits affect balance and motor function in children with cerebral palsy. Frontiers in Human Neuroscience 2020; 14: 45. 4. Tatemoto T, Tanaka S, Maeda K, Tanabe S, Kondo K, Yamaguchi T. Skillful cycling training induces cortical plasticity in the lower extremity motor cortex area in healthy persons. Frontiers in Neuroscience 2019; 13: 927.

    RESULT

MeSH Terms

Conditions

Cerebral PalsyGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Umair Ahmed, PhD

    University of Lahore

    STUDY CHAIR

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
SPONSOR

Study Record Dates

First Submitted

February 18, 2023

First Posted

August 13, 2025

Study Start

January 22, 2023

Primary Completion

June 25, 2023

Study Completion

July 10, 2023

Last Updated

August 13, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations