Comparative Effects of Spider Cage Therapy and Modified Suit Therapy in CP

NCT ID: NCT06198257

Last Updated: 2024-06-13

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

2023-12-01

Study Completion Date

2024-02-05

Brief Summary

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Spider Cage is a part of universal exercise unit. It is a suspension system, which works with use of belts, elastic cords and Thera suits (Thera suits especially for cerebral palsy). Cords are dynamic and provides an appropriate amount of support with the help of which patient can perform movement independently. Cerebral Palsy (CP) is a condition where non progressive disorders of posture caused by abnormal development of, or damage to, motor control centers of brain resulting in abnormal movements.

Detailed Description

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It will be Randomized Controlled trial in which non probability convenience sampling technique will be used. Two groups of 8 to 12 age will be formed in which participants will be randomly divided by lottery method. Group A will be given modified Thera suits and the other group B will receive spider cage therapy on trunk stability and pelvic control. Improvement will be identified by Trunk Control Measurement Scale (TCMS), Trunk impairment scale (TIS) and Gross motor function classification system. (GMFCS) level I-II. The result after statistical analysis will show that which treatment will be more effective. Results will be analyzed on SPSS 29. Data analyzed by repeated measures ANOVA

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It will be Randomized Controlled trial in which non probability convenience sampling technique will be used. Two groups of 8 to 12 age will be formed in which participants will be randomly divided by lottery method. Group A will be given modified Thera suits and the other group B will receive spider cage therapy on trunk stability and pelvic control.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will get seperate treatment protocols and possible efforts will be put to mask the both groups about their treatment.

Study Groups

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group A

Spider cage therapy along with strengthening exercises

Group Type ACTIVE_COMPARATOR

spider cage

Intervention Type DEVICE

5 days a week for an hour/daily with conventional exercises. Assisted sit to stand (10 to 15---15 to 20) Assisted weight shift (10 to 15---15 to 20) Assisted trunk rotation (10 to 15---15 to 20) Hip Abd / Add. exercises (10 to 15---15 to 20) Bridge exercises (10 to 15---15 to 20)

group B

Modified suits therapy along with strengthening exercise

Group Type ACTIVE_COMPARATOR

modified suits therapy

Intervention Type DEVICE

5 days a week for an hour/daily with conventional exercises. Assisted sit to stand (10 to 15---15 to 20) Assisted weight shift (10 to 15---15 to 20) Assisted trunk rotation (10 to 15---15 to 20) Hip Abd / Add. exercises (10 to 15---15 to 20) Bridge exercises (10 to 15---15 to 20)

Interventions

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spider cage

5 days a week for an hour/daily with conventional exercises. Assisted sit to stand (10 to 15---15 to 20) Assisted weight shift (10 to 15---15 to 20) Assisted trunk rotation (10 to 15---15 to 20) Hip Abd / Add. exercises (10 to 15---15 to 20) Bridge exercises (10 to 15---15 to 20)

Intervention Type DEVICE

modified suits therapy

5 days a week for an hour/daily with conventional exercises. Assisted sit to stand (10 to 15---15 to 20) Assisted weight shift (10 to 15---15 to 20) Assisted trunk rotation (10 to 15---15 to 20) Hip Abd / Add. exercises (10 to 15---15 to 20) Bridge exercises (10 to 15---15 to 20)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • 8 to 12 years of age

* Both male and female
* Hemiplegic cerebral palsy according to (GMFCS) severity level I-II
* Ability to follow instructions and participate in therapy session

Exclusion Criteria

* • Presence of any medical conditions that would severely limit a child's participation in the study as vision or hearing loss, cardiac anomalies.

* severe cognitive impairments that would hinder the participant's ability to actively participate in therapy sessions.
* Complicated systemic disorders.
* Uncontrollable seizures.
* Usage of Botulinum toxin A injection within 3 months of prior
Minimum Eligible Age

8 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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Izzah Bukhtawar, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Martins E, Cordovil R, Oliveira R, Letras S, Lourenco S, Pereira I, Ferro A, Lopes I, Silva CR, Marques M. Efficacy of suit therapy on functioning in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2016 Apr;58(4):348-60. doi: 10.1111/dmcn.12988. Epub 2015 Nov 27.

Reference Type BACKGROUND
PMID: 26613800 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/23/0764

Identifier Type: -

Identifier Source: org_study_id

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