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NCT Number: NCT06781047

Effects of Trunk-Focused Rehabilitation on Spinal Mobility, Trunk Control, and Hand Functions in Cerebral Palsy

Main Purpose: This study aims to investigate the effects of trunk-focused rehabilitation on trunk control, spinal mobility, and manual skills in adolescents with cerebral palsy (CP).

Secondary Purpose: To investigate its effects on functional health.

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Key information

Conditions

Cerebral Palsy (CP) Adolescent Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Exercise Motor Activity Nervous System Diseases Trunk

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Etimesgut Kardelen Special Education and Rehabilitation Center, Ankara, Etimesgut, Turkey (Türkiye)

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About this study

Muscle weakness in the trunk; reducing the support of children with CP, may cause increased distal tone and decreased function in their daily practices. When the effectiveness of interventions that can improve postural control is evaluated, trunk-focused training is one of the 5 interventions supported by a moderate level of evidence. In an intervention study where trunk training was structured individually, there may be an improvement in erector spinae muscle group scores when evaluated with sEMG. A study of 28 cases, including all subtypes of CP, aimed to evaluate the inter-rater reliability of Spinal Mouse (SM) and the effect on the spinal column with 4 hours a day, 1 week of intensive clinical rehabilitation application. In this population, SM was evaluated with therapeutic interventions, it has been reported that it may show significant posture differences, especially in total spinal inclination and spine length. In children aged 5-12 years with Gross Motor Function Classification System (GMFCS) Level 1, 2 CP, there are significant improvements in the Trunk Control Measurement Scale (TCMS) score after only Trunk Focused Rehabilitation (TFR). It is emphasized that with TFR, which is described as a unique approach, postural control of the whole body can be improved by the use of intermediate postures and postural activities involving the trunk and better participation of the affected muscles. Only after TFR intervention, the findings of improvement in the assessments on a 3D force platform were highlighted in postural sway, early sternal and sacral decelerations. It is carried out with active participation, individualized, intensive, and time-limited, considering possible content limitations and the needs and preferences of the adolescent and the family. It is stated that trunk-targeted interventions can be given together with conventional physical therapy programs to support functional improvements.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Levels 1 and 2 according to Gross Motor Function Classification System (GMFCS)
  • Viking Speech Scale Turkish version/(VSS-T) 1-2 level, understood to speak and able to take commands
  • Adolescents with CP between the ages of 12-18
  • Those whose guardian / legal representative and themselves have received an Informed Voluntary Consent Form
  • No hip dislocation
  • Scoliosis below 25 degrees according to the radiographic evaluation made in the last 6 months

Exclusion criteria

  • Having had any surgery related to the intrathecal baclofen pump
  • Having botulinum toxin injection treatment or orthopedic surgery within the last 6 months
  • Having severe vision, hearing, and cognitive deficiencies
  • Acute medical illness

Treatment and study plan

Trunk Focused Rehabilitation (TFR)

Other

Abdominal stabilization progression for TFR is applied with simultaneous breathing exercise for 3 days a week, 45 minutes a day, 8 weeks (24 sessions in total)(8).

  • Basic Abdominal Stabilization Training, Task-Focused Exercises (without spinal diagonal and rotational components)(8,12).

Warm-up: 5 minutes, Global Stretching and Relaxation(9,10,11). Extremity load, elastic band, and unstable surface are added as stabilization is achieved in neurodevelopmental positions. Task-oriented exercises(12).

Cooling Down: Warm-up exercises are repeated.

  • General Posture and Asymmetry Training Brochure (includes adolescent, family, and team members)(13-17).

The exercise starts with 3 seconds and gradually progresses to 10 seconds, 10 repetitions, and 3 sets.

The TFR group also receives Conventional Treatment 2 days a week, 40 minutes per day, for 8 weeks. The same treatment protocol is applied as the control group). Routine physiotherapists apply conventional treatment.

Conventional rehabilitation (CR)

Other

Conventional treatment is applied to the group, 2 days a week, 40 minutes each session, for 8 weeks. It is an intervention performed by a physiotherapist who regularly follows up in a special education and rehabilitation center.

  • Normal Joint Movement (NEH)
  • Stretching for the lower, and upper extremities and around the hips
  • Lying activities
  • Curl up (assisted, unaided)
  • Bridging exercise, cat camel exercise, posterior pelvic tilt exercise
  • Walking training
  • Climbing and descending stairs
  • Weight transfer exercises at standing, sitting

Primary outcomes

  1. Evaluation of Trunk Control

    Time frame: at baseline and week 9

    Trunk Impairment Scale: It consists of coordination, dynamic and static sections. In the static section, the responses in actively and passively crossing the legs with the feet in a supported position are recorded. In the dynamic section, unilateral hip movements and lateral flexion of the trunk are evaluated. In the coordination section, the upper and lower body are asked to move. Coordination consists of dynamic and static sections. The maximum scores that can be obtained from the tests are 7 for the static section, 10 for the dynamic section, and 6 for the coordination section. The score range is 0-23. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.

  2. Evaluation of Spinal Mobility

    Time frame: at baseline and week 12

    Spinal Mobility and Alignment Assessment (Sagittal Plane): Spinal Mouse (SM) measurements are taken at the same time of day, in an environment where the patient is resting, distrubating their weight equally between their two feet as much as possible, and standing symmetrically, while the patient is standing upright in an anatomical position, by moving downwards at a constant speed over the SM spinal criterion points (from C7 spinous process to S3) by the physiotherapist. The spine is measured 3 times in the sagittal plane. The average value of the measurements is used for analysis.

  3. Evaluation of Hand Functions

    Time frame: at baseline and week 9

    Jebsen Taylor Hand Function Test (JTHFT): Writing, card turning, picking up small objects, large and heavy objects skills and durations are assessed in both hands. 7 items are repeated for both hands. The completion time of each task is recorded separately. The score for the subtest is equal to the time in seconds required to complete the task, the maximum score for the subtest is 120. The total score is equal to the sum of points for all subtests and is calculated separately for each hand. The lower the score, the better the child's hand function.

Secondary outcomes

  1. 1 Minute Walking Test (1-MWT):

    Time frame: at baseline and week 9

    The 1-minute walk test (1-MWT) is a valid and simple assessment for monitoring changes in walking capacity in children with chronic conditions. While performing the 1-MWT, children are asked to walk as fast as they can on a circular track. Running is prohibited. They may use mobility aids if necessary. The distance they travel on the track is recorded.

  2. Pediatric Data Collection Tool (PODCI)

    Time frame: at baseline and week 9

    PODCI consists of 5 subscales: Upper Extremity and Physical Function, Transfer and Basic Mobility, Pain/Comfort, Happiness, Sports and Physical Function, and Global Function. PODCI scores are calculated separately for each subscale and range from 0 to 100 points. Higher scores represent better health. The PODCI includes 86 items in 3 scales: global function, happiness, and expectations. The global function scale is the average of 4 subscales: upper extremity and physical function, transfers and basic mobility, sports and physical function, and pain and comfort. Items are scored ranging from 0 to 3 and 0 to 6, with lower scores indicating higher disability level.

Study contacts

Contact information is provided by the study sponsor or research team.

Gül EVDALI, MScPT

CONTACT

[email protected]

+90 544 368 60 26 ext. +90

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Serebral Palsili Adölesanlarda Gövde Odaklı Rehabilitasyonun Spinal Mobilite, Gövde Kontrolü ve El Fonksiyonları Üzerine Etkilerinin İncelenmesi

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Feb 7, 2025

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

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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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