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Completed

NCT Number: NCT06198257

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. Trunk Impairment Scale (TIS).

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Trunk Control Measurement Scale (TCMS).

    Time frame: 8 weeks

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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