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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05460936
Other study ID # REC/RCR& AHS /22/0715
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 18, 2022
Est. completion date November 25, 2022

Study information

Verified date November 2022
Source Riphah International University
Contact wajiha shahid, phd
Phone 03214885079
Email wajiha.shahid@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 22
Est. completion date November 25, 2022
Est. primary completion date November 15, 2022
Accepts healthy volunteers No
Gender All
Age group 7 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan International Therapy Services Center Lahore Punjab
Pakistan Rising Sun Institute Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Baldon Rde M, Serrão 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 8th week
Primary 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 8th week
Primary 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. 8th Week
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