Effect of PSSE on Plantar Pressure Distribution and Balance in Scoliosis

NCT04226209 | Unknown

• 1 other identifier: 52010
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of the study is to investigate the effect of Physiotherapeutic Scoliosis-Specific Exercises (PSSE) on Plantar Pressure Distribution and Balance in Adolescent Idiopathic Scoliosis (AIS). Twenty-four patients with AIS will randomly allocated to two groups. 'Schroth' exercises will apply to the PSSE group for 8 weeks (16 sessions). The control group will teach basic elements. Patients' maintenance of posture during both static and dynamic conditions (Biodex Balance System SD), distribution of foot pressure (Baropedometric Platform), foot posture (Foot Posture Index), frontal-sagittal plan posture (PostureScreen Mobile Application), body symmetry (Anterior Trunk Asymmetry Index and Posterior Trunk Asymmetry Index), deformity perception (The Walter Reed Visual Assessment Scale), quality of life (Pediatric Quality of Life Scale and SRS-22), spinal pain (Visual Analogue Scale) will assess at the first session and at the end of 8 weeks.

Conditions

Scoliosis; Adolescence; Physiotherapy; Exercise; Balance

Keywords

scoliosis; PSSE; balance; plantar pressure

Outcome Measures

Primary Outcomes (4)

• Biodex Balance System SD

  It is a multi-axial device used to measure an individual's maintenance of posture during both static and dynamic conditions. a)Test for static conditions: the participant were instructed to shift their weight to move a cursor toward each red, blinking target as displayed on the screen as quickly and with as much accuracy as possible. If a participant were to score a 100%, this would suggest that the individual moved in a precise and straight line to each target; higher percentage thus reflected better performance. b)Test for dynamic conditions: (1) Eyes Open, Firm Surface, (2) Eyes Closed, Firm Surface, (3) Eyes Open, Foam Surface, and (4) Eyes Closed, Foam Surface. For each of the four conditions, each participant was instructed to stand as still as they possibly could for the entire 30 seconds.The Overall Sway Index was recorded. Higher scores on the stability indices demonstrate a greater amount of postural sway or variability during that particular condition.

  8 week

• Baropedometric Platform

  It allows for the analysis of the distribution of foot pressure on the ground. The platform consists of three elements and it is connected to a computer, where the transmitted data is saved and analyzed. During the test procedure, the following results could obtain: (a) average maximum loads \[gr/cm2\], (b) average loads \[gr/cm2\], (c) average foot area \[cm2\] and (d) right and left foot load distribution \[%\].

  8 week

• Foot Posture Index (FPI-6)

  Foot Posture Index was used to assess the foot posture during full weight bearing. Six sub-measurements were performed, rated from +2 (highly pronated) to -2 (highly supinated) and summed up to an overall score. The sub-measurements consisted of the talar head palpation, supra and infra lateral malleolar curvature, calcaneal frontal plane position, prominence of the region of the talonavicular joint, congruence of the medial longitudinal arch and abduction/adduction of the forefoot on the rear foot. If the overall score was positive it indicated a pronated foot posture compared to a negative score, indicating a supinated foot.

  8 week

• Adams forward bending test

  The subjects were in the standing position and both feet were given equal weight; cases are asked to lean forward. The measurement can be combined with a scoliometer. The scoliometer is placed parallel to the ground and measured between T1 and L5. During the measurement, care is taken that the body is parallel to the ground and the arms are loose. Baseline Scoliometer will be used for evaluations. Decreased degree is considered to be improvement.

  8 week

Secondary Outcomes (7)

• Frontal-sagittal plan posture evaluation

  8 week

• Body Symmetry

  8 week

• Body Symmetry

  8 week

• Deformity perception assessment

  8 week

• Health-related quality of life assessment

  8 week

Study Arms (2)

PSSE

EXPERIMENTAL

Physiotherapeutic Scoliosis-Specific Exercises PSSE group will receive corrective exercise for scoliosis

Other: PSSE

Control

NO INTERVENTION

Control group will be taken to the queue list.

Interventions

PSSE OTHER

Physiotherapeutic Scoliosis-Specific Exercises (PSSE) group will receive exercise for 30-40 mins in a day, twice in a week, totally 8 weeks and 16 hours. Control group will be taught the basic elements of corrective exercises and want them to do the practising during 8 weeks at home.

Also known as: Control

PSSE

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• To have diagnosis of Adolescence Idiopathic Scoliosis
• To be in between 10-17 years
• To be the Cobb angle which determined in Anteroposterior graphy as between 10-45 degree
• To not having any other exercise attitude about scoliosis before.

You may not qualify if:

• Spinal surgery or tumor history
• Accompanying mental, rheumatologic, neuromuscular, cardiovascular, pulmonary disease history
• Vision and / or hearing loss
• Disease history related to balance and vestibular system
• Injury or involvement of the lower extremities that may affect balance

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Istanbul University: collaborator

Study Sites (1)

Istanbul University Cerrahpasa, Faculty of Health Science

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: March 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: September 1, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

TU (1)