Lower Extremity Functional Training (LIFT) on Gross Motor Function and Gait in Children With Spastic CP (LIFT)

November 8, 2022 updated by: Riphah International University

Effects of Lower Extremity Functional Training (LIFT) on Gross Motor Function and Gait in Children With Spastic Cerebral Palsy

Cerebral Palsy is a developmental disorder caused by damage to the brain before, during or after birth. Spastic Cerebral Palsy is one of the most common types of cerebral Palsy. It affects about 80% of cerebral palsy. Spastic CP is characterized by increased muscle tone, jerky movements, joint stiffness, and muscle tightness. Spastic Cerebral primarily affects strength, coordination, and balance resulting in gait difficulties and affecting gross motor functioning. These abnormalities affect the very basic activities of daily life (ADLs). Even if the child is able to walk the motor skills are usually disturbed which are very important to improve and maintain gross motor functioning. Physical therapy plays a vital role in overcoming these issues.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the previous studies the effects of LIFT on the trunk and core has been studies however, the data on the effects on the gross motor skills are very less. In addition to that the effects of lower extremity functional training on the gait have also been limited to a few studies only. The past studies were of very short time period due to which the proper effects of LIFT on the gait and gross motor skills were not very well understood.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 40050
        • Recruiting
        • International Therapy Services Center
        • Principal Investigator:
          • Abdul Mannan, MS (PPT)
      • Lahore, Punjab, Pakistan, 40050
        • Recruiting
        • Rising Sun Institute
        • Principal Investigator:
          • Abdul Mannan, MS (PPT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are not able to stand
  • Age between 7 to 16 years
  • Patients living near the designated center

Exclusion Criteria:

  • Patients with comorbidities
  • Patients with cognitive impairment
  • Patients who are not able to follow commands
  • Patients with a history of falls

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: conventional physical therapy
Resistive Exercises Stretching exercise of quadriceps , hamstring adductors and abductors.
Other: conventional physical therapy
Resistive Exercises Stretching exercise of quadriceps , hamstring adductors and abductors.
EXPERIMENTAL: Lower Extremity Functional Training
motor learning, skill progression, and resistance training to target the balance, strength, and coordination impairments of the lower extremities. Motor learning will be based on strength and balance training using tandem walks, balance boards, and one-leg standing. Skill progression will be used to challenge the LIFT and the strength training will be achieved by performing sit-to-stand, sit-ups, stair climbs, and vertical jumps
Other: Lower Extremity Functional Training
motor learning, skill progression, and resistance training to target the balance, strength, and coordination impairments of the lower extremities. Motor learning will be based on strength and balance training using tandem walks, balance boards, and one-leg standing. Skill progression will be used to challenge the LIFT and the strength training will be achieved by performing sit-to-stand, sit-ups, stair climbs, and vertical jumps

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1-minute walk test
Time Frame: 8th week
1-minute walk test will be used to measure the functional ability of the child. This is a cost-effective and user-friendly tool which makes it a very suitable tool to be used in various clinical settings. This tool is selected because of the low attention span and ability of children to perform other tests. This test can be conducted in a short duration of time giving the required results
8th week
Single leg stance
Time Frame: 8th week
a. The single-leg stance test is used to check the balance control along with the static posture control on the affected side. This tool is considered valuable and effective in monitoring the musculoskeletal; status and neurological status of the individual
8th week
Gross Motor Function Measurement
Time Frame: 8th Week
The Gross Motor Function Measure31 is a criterion-referenced assessment designed to be used with children with cerebral palsy. It evaluates the child's ability to complete motor functions, such as rolling, crawling, sitting, standing, walking, running, stair use, and jumping.
8th Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR& AHS /22/0715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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