Loaded Vs Unloaded Sit to Stand Strengthening Exercises in Children With Cerebral Palsy

NCT ID: NCT06190418

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-03-30

Brief Summary

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Cerebral palsy(CP) is non-progressive disorder, undergo mishap to the developing brain and it affect a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease". Cerebral means having to do with the brain. Palsy means weakness or problems with using the muscles. In Spastic diplegic, muscle stiffness is mainly in the legs, with the arms less affected or not affected at all. The most common cause of spastic diplegia is Periventricular leukomalacia, more commonly known as neonatal asphyxia or infant hypoxia-a sudden in-womb shortage of oxygen-delivery through the umbilical cord. Strength exercise is any activity that makes your muscles work harder than usual.

The significance of this study is that it will define whether loaded or unloaded sit to stand strengthening exercises have good effect on muscle strength and energy expenditure in diaplegic CP. This will be a randomized clinical trial, data will be collected from District Head Quarter DHQ hafizabad. Study will be conducted on 32 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 and 2 and those who are able to stand up from chair independently and maintain standing for more than 5 seconds without falling will be included.Diplegic CP children who had not received any strengthening exercise program in past 3 months and those less than 20 degrees limitation in passive range of motion in hip flexion will be included. Those diplegic spastic CP who have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past six months and orthopedic conditions or medical problems that prevented children from participating in exercises will be excluded. Group A will be provided with loaded sit to stand strengthening exercises. 1 repetition maximum(1-RM) will be used as loaded sit to stand test. Group B will be provided with unloaded sit to stand strengthening exercises. Pre and post session lower limb functional strength will be measured by performing functional strength tests while lower limb muscular strength will be measured via modified sphygmomanometer and physiological cost index will be measured to rule out energy expenditure.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Loaded sit to stand strengthening exercise group

This group will be provided with loaded sit to stand strengthening exercises in spastic diplegic children.1 repetition maximum of the load will be provided. Exercise will be conducted 3 times a week for 6 weeks, pre and post session functional strength of lower limb will be measured by performing functional strength tests and physiological cost index will be measured to calculate energy expenditure.

Group Type ACTIVE_COMPARATOR

Loaded sit to stand strengthening exercise

Intervention Type OTHER

This Group will be given with the wieghted vest equal to that of 1RM for each child and Sit-to-Stand Strengthening Excerise will be given 3 times per week for 6 weeks

Unloaded sit to stand strengthening exercise group

This Group will be provided with unloaded sit to stand exercises in diplegic spastic CP, 3 times a week for 6 weeks. Pre and post session functional strength of lower limb muscles will be measured by performing functional strength tests and physiological cost index will be measured to determine energy expenditure.

Group Type ACTIVE_COMPARATOR

Unloaded sit to stand strengthening exercise

Intervention Type OTHER

This Group will be given with the Sit-to-Stand Strengthening Excerise without any external load for 3 times per week for 6 weeks

Interventions

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Loaded sit to stand strengthening exercise

This Group will be given with the wieghted vest equal to that of 1RM for each child and Sit-to-Stand Strengthening Excerise will be given 3 times per week for 6 weeks

Intervention Type OTHER

Unloaded sit to stand strengthening exercise

This Group will be given with the Sit-to-Stand Strengthening Excerise without any external load for 3 times per week for 6 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Spastic diplegic cerebral palsy
* Age between 6 to 12 years
* Children with GMFCS level I and II
* Able to stand up from chair independently and maintain standing for more than 5 second without falling.
* Had not received any strengthening exercise program in past 3 months
* Parental commitment to allow participation without altering current activity

Exclusion Criteria

* Participants with epileptic history and lower limb contractures are excluded
* Those who are unable to follow verbal command
* Have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past 6 months
* Orthopedic condition or medical problems that prevent children from participating in exercise
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wasifa Rauf, MSPT(Peads)

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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District Headquarter Hospital,

Hafizabad, , Pakistan

Site Status

Countries

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Pakistan

References

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Kusumoto Y, Nitta O, Takaki K. Impact of loaded sit-to-stand exercises at different speeds on the physiological cost of walking in children with spastic diplegia: A single-blind randomized clinical trial. Res Dev Disabil. 2016 Oct;57:85-91. doi: 10.1016/j.ridd.2016.06.006. Epub 2016 Jul 7.

Reference Type BACKGROUND
PMID: 27394691 (View on PubMed)

Lee J, Suk MH, Yoo S, Kwon JY. Physical Activity Energy Expenditure Predicts Quality of Life in Ambulatory School-Age Children with Cerebral Palsy. J Clin Med. 2022 Jun 11;11(12):3362. doi: 10.3390/jcm11123362.

Reference Type BACKGROUND
PMID: 35743433 (View on PubMed)

Liao HF, Liu YC, Liu WY, Lin YT. Effectiveness of loaded sit-to-stand resistance exercise for children with mild spastic diplegia: a randomized clinical trial. Arch Phys Med Rehabil. 2007 Jan;88(1):25-31. doi: 10.1016/j.apmr.2006.10.006.

Reference Type BACKGROUND
PMID: 17207671 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/23/0729

Identifier Type: -

Identifier Source: org_study_id

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