- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05460936
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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
22
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: conventional physical therapy
Resistive Exercises Stretching exercise of quadriceps , hamstring adductors and abductors.
|
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
|
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
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
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
- Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Sports Health. 2019 Mar/Apr;11(2):149-156. doi: 10.1177/1941738118821929. Epub 2019 Jan 14.
- Baldon Rde M, Serrao FV, Scattone Silva R, Piva SR. Effects of functional stabilization training on pain, function, and lower extremity biomechanics in women with patellofemoral pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Apr;44(4):240-251, A1-A8. doi: 10.2519/jospt.2014.4940. Epub 2014 Feb 25.
- Vereijken A, Aerts I, Jetten J, Tassignon B, Verschueren J, Meeusen R, van Trijffel E. Association between Functional Performance and Return to Performance in High-Impact Sports after Lower Extremity Injury: A Systematic Review. J Sports Sci Med. 2020 Aug 13;19(3):564-576. eCollection 2020 Sep.
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)
May 18, 2022
Primary Completion (ANTICIPATED)
November 15, 2022
Study Completion (ANTICIPATED)
November 25, 2022
Study Registration Dates
First Submitted
July 14, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (ACTUAL)
July 15, 2022
Study Record Updates
Last Update Posted (ACTUAL)
November 9, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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