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

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Lower Extremity Functional Training
conventional physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy. gait training, motor learning, functional training, balance, hemiplegic gait.

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • International Therapy Services CenterRecruiting
  • Rising Sun InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional physical therapy

Lower Extremity Functional Training

Arm Description

Resistive Exercises Stretching exercise of quadriceps , hamstring adductors and abductors.

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

Outcomes

Primary Outcome Measures

1-minute walk test
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
Single leg stance
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
Gross Motor Function Measurement
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.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2022
Last Updated
November 8, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05460936
Brief Title
Lower Extremity Functional Training (LIFT) on Gross Motor Function and Gait in Children With Spastic CP
Acronym
LIFT
Official Title
Effects of Lower Extremity Functional Training (LIFT) on Gross Motor Function and Gait in Children With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
November 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy. gait training, motor learning, functional training, balance, hemiplegic gait.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional physical therapy
Arm Type
Active Comparator
Arm Description
Resistive Exercises Stretching exercise of quadriceps , hamstring adductors and abductors.
Arm Title
Lower Extremity Functional Training
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Lower Extremity Functional Training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conventional physical therapy
Intervention Description
Resistive Exercises Stretching exercise of quadriceps , hamstring adductors and abductors.
Primary Outcome Measure Information:
Title
1-minute walk test
Description
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
Time Frame
8th week
Title
Single leg stance
Description
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
Time Frame
8th week
Title
Gross Motor Function Measurement
Description
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.
Time Frame
8th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wajiha shahid, phd
Phone
03214885079
Email
wajiha.shahid@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wajiha Shahid, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Therapy Services Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
40050
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wajiha shahid, phd
Phone
03036088768
Email
wajiha.shahid@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Abdul Mannan, MS (PPT)
Facility Name
Rising Sun Institute
City
Lahore
State/Province
Punjab
ZIP/Postal Code
40050
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wajiha shahid, phd
Phone
03036088768
Email
wajiha.shahid@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Abdul Mannan, MS (PPT)

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24568258
Citation
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.
Results Reference
background
PubMed Identifier
32874110
Citation
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.
Results Reference
background
PubMed Identifier
30638439
Citation
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.
Results Reference
background

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

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