Treadmill Training at Variable Inclinations in Children With Cerebral Palsy

NCT06216652 | Completed

• 1 other identifier: PamukkaleU-SBF-BR-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effect of treadmill training (TT) at different inclinations on balance, strength, flexibility, and gait parameters in children with cerebral palsy (CP) in addition to traditional physiotherapy applications. Forty-two participants with CP aged 7-18 years and at Gross Motor Function Classification System level 2 were randomized into three groups: downhill walking (DW), uphill walking (UW), and walking with no incline (WWI). Balance, isometric strength, flexibility, and gait parameters were assessed at baseline (2nd week) and at 11th week. The groups were provided with TT and conventional treatment. All groups showed improvement in balance. Isometric strength values showed improvement in knee flexion (KF) on the affected side (AS) in DW and UW groups, and in knee extension force in UW and WWI groups. In flexibility, hip flexion, hip extension and ankle dorsiflexion improved in all groups, while KF and ankle plantar flexion improved only in DW and WWI. Duration of the modified timed up-and-go test showed significant improvements in the DW and UW groups. TT performed at different inclinations improved balance, isometric strength, flexibility, and gait parameters on both the AS and the nonaffected side.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (4)

• Balance

  Dynamic balance was assessed using the functional reach test (FRT), one of the physical fitness parameters, which is a reliable and valid assessment tool for assessing balancing ability among children with CP. The results were recorded in centimeters and statistics were made on their averages.

  8 weeks

• Isometric muscle strength

  The isometric muscle strength, one of the physical fitness parameters, is a reliable assessment tool for assessing isometric strength among children with CP. The isometric muscle strength of the participants' knee flexor and extensor muscles was evaluated with a hand dynamometer (JTECH Medical PowerTrack II Commander, Salt Lake City, UT, USA). The results were recorded in newton and statistics were made on their averages.

  8 weeks

• Flexibility

  Range of motion measurements, one of the physical fitness parameters, were performed manually with a goniometer. The results were recorded in degree and statistics were made on their averages.

  8 weeks

• Spatiotemporal gait analysis

  Gait performance, one of the physical fitness parameters, was assessed with the LEGSystm spatiotemporal gait analyzer (LegSys/BioSenics, Watertown, USA). The results were recorded as time (s and min), distance (m) and step frequency (step/min), and statistics were made on their averages.

  8 weeks

Study Arms (3)

downhill walking

ACTIVE COMPARATOR

All participants received a conventional physiotherapy program. In addition to this program, the first group performed downhill walking exercise on the treadmill

Other: downhill walking

uphill walking

ACTIVE COMPARATOR

All participants received a conventional physiotherapy program. In addition to this program, the second group performed uphill walking exercise on the treadmill

Other: uphill walking

walking with no incline

ACTIVE COMPARATOR

All participants received a conventional physiotherapy program. In addition to this program, the third group performed walking with no incline exercise on the treadmill

Other: walking with no incline

Interventions

downhill walking OTHER

All participants received a conventional physiotherapy program for 2 days/week, 40 min/day for 8 weeks. In addition to this program, the first group performed downhill walking exercise on the treadmill for 2 days/week, 30 min/day on different days.

downhill walking

uphill walking OTHER

All participants received a conventional physiotherapy program for 2 days/week, 40 min/day for 8 weeks. In addition to this program, the second group performed uphill walking exercise on the treadmill for 2 days/week, 30 min/day on different days.

uphill walking

walking with no incline OTHER

All participants received a conventional physiotherapy program for 2 days/week, 40 min/day for 8 weeks. In addition to this program, the third group performed walking with no incline walking exercise on the treadmill for 2 days/week, 30 min/day on different days.

walking with no incline

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age between 7-18 yrs old,
• being at Gross Motor Functional Classification System (GMFCS) levels II,
• no cooperation problems that would interfere with communication,
• no surgical treatment or neuromuscular injection in the last 6 months
• no unstoppable epileptic seizures,
• asymmetric lower extremity shortness \>4 cm and no any health problems except CP.

You may not qualify if:

• trauma during the study period,
• not participating in the exercise program by more than 20%, willing to quit voluntarily,
• having a spasticity ≥2 on the Modified Ashworth Scale (MAS) measured from the lower extremity

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Walking

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Berna Ramanlı

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: November 10, 2021
• Primary Completion: February 10, 2022
• Study Completion: March 10, 2022
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

TU (1)