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

NCT06198257 | Completed

• 1 other identifier: REC/RCR&AHS/23/0764
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Keywords

CP; Pelvic control; Spider cage therapy; modified Thera suits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Trunk Control Measurement Scale (TCMS).

  8 weeks

Study Arms (2)

group A

ACTIVE COMPARATOR

Spider cage therapy along with strengthening exercises

Device: spider cage

group B

ACTIVE COMPARATOR

Modified suits therapy along with strengthening exercise

Device: modified suits therapy

Interventions

spider cage 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 A

modified suits therapy 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

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related 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.

  PMID: 26613800 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Izzah Bukhtawar, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get seperate treatment protocols and possible efforts will be put to mask the both groups about their treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 10, 2024
• Study Start: December 1, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)