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

NCT ID: NCT07121426

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-22
• Study Completion Date: 2023-07-10

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.

Detailed Description

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.

Conditions

Spastic Diplegic Cerebral Palsy; Gait, Spastic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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

Group Type: EXPERIMENTAL

Conventional physical therapy

Intervention Type: 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.

Intervention Group

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

Group Type: EXPERIMENTAL

Lower limb Intensive Functional Training

Intervention Type: 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

Intervention Type: 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.

Interventions

Lower limb Intensive Functional Training

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 Type: OTHER

Conventional physical therapy

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Umair Ahmed, PhD

Role: STUDY_CHAIR

University of Lahore

Locations

Husna Albab

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

REC-UOL-287-01-2023

Identifier Type: -

Identifier Source: org_study_id