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

Cerebral Palsy Clinical Trial

Official title:

Comparative Effects of Spider Cage Therapy and Modified Suit Therapy on Trunk Stability and Pelvic Control in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06198257
• Other study ID #: REC/RCR&AHS/23/0764
• Status: Completed
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: February 5, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• 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)
• 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)

Locations

Country	Name	City	State
Pakistan	Riphah International University	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trunk Impairment Scale (TIS).	The static subscale. The dynamic subscale; For each item, a 2-, 3- or 4-point ordinal scale is used. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance. In a recent version of the TIS (version 2.0) for adults, the static subscale was removed because of a ceiling effect, total score ranges between 0 and 16 points.	8 weeks
Secondary	Trunk Control Measurement Scale (TCMS).	The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control, and 10 to the ability to perform dynamic reaching TCMS sub scores appeared to be clinically relevant because children with less than around 80% of the static balance score, less than 55% of the dynamic reaching score, or less than around 35% of the selective movement control score needed support for daily life activities	8 weeks