Cerebral PalsyNCT06216652
Treadmill Training at Variable Inclinations in Children With Cerebral Palsy
A study testing downhill walking, uphill walking and walking with no incline in people with Cerebral Palsy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- downhill walking, uphill walking and walking with no incline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2021to 10 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Balance, Strength, Flexibility and Spatiotemporal Gait Parameters in Pediatric Cerebral Palsy: Treadmill Training at Variable Inclinations
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.
Read more
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.
Read the detailed description
TT is a therapeutic technique in the rehabilitation of children with CP. Positive effects of different TT protocols have been observed in patients with CP; however, there is no study examining the effects of forward downhill TT. Therefore, this study aimed to investigate the effect of TT with forward downhill walking (DW), forward uphill walking (UW), and forward walking with no incline (WWI) on balance, strength, flexibility, and gait parameters in 7-18-year-old children with hemiparetic and diparetic CP in addition to traditional physiotherapy applications.
Sixty-four participants were initially recruited in this study. However, 42 participants (18 female, 24 male) with hemiparetic and diparetic CP completed the study. The study was conducted in a Special Education and Rehabilitation Center in Denizli, Turkey between April 2021 and June 2022. The inclusion criteria for the study were (a) age between 7-18 yrs old, (b) being at Gross Motor Functional Classification System (GMFCS) levels II, (c) no cooperation problems that would interfere with communication, (d) no surgical treatment or neuromuscular injection in the last 6 months (e) no unstoppable epileptic seizures, (f) asymmetric lower extremity shortness >4 cm and no any health problems except CP. Exclusion criteria from the study were 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 All parents/guardians agreed to the participation of their children by signing a statement of informed consent. The investigation was approved by the Pamukkale University Clinical Research Ethics Committee (60116787-020-35801/24.03.2021). All procedures were realized in according to the Declaration of Helsinki.
To ensure that the gender and age distributions to be observed in the groups were similar, a randomization table was prepared by stratified randomization method before the study.
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 DW TT, the second group performed UW TT, and the third group performed WWI TT walking exercise on the treadmill for 2 days/week, 30 min/day on different days. At the beginning and end of the 8-week program, the participants' lower extremity isometric strength was assessed using a hand-held dynamometer, dynamic balance was assessed using a functional reach test (FRT), flexibility was assessed range of motion (ROM) using a goniometer, and gait performance was assessed using a spatiotemporal gait analyzer. All measurements included familiarization trials. Conventional physiotherapy program, walking exercises, and measurements were conducted in standard conditions (22-25 °C, 25%-45% relative humidity) during the morning hours in a quiet room by the same physiotherapist.
- Conditions
- Cerebral Palsy
- Being tested
- downhill walking, uphill walking, walking with no incline
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
downhill walkingOther
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.
uphill walkingOther
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.
walking with no inclineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: walking with no incline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start10 Nov 2021
- Primary completion10 Feb 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Ramanli, Pamukkale University
- Investigators
- Berna Ramanlı, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216652
- Sponsor's protocol ID
- PamukkaleU-SBF-BR-01
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Balance, Strength, Flexibility and Spatiotemporal Gait Parameters in Pediatric Cerebral Palsy: Treadmill Training at Variable Inclinations
- ClinicalTrials.gov ID
- NCT06216652
- Acronym / sponsor ID
- PamukkaleU-SBF-BR-01
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TT is a therapeutic technique in the rehabilitation of children with CP. Positive effects of different TT protocols have been observed in patients with CP; however, there is no study examining the effects of forward downhill TT. Therefore, this study aimed to investigate the effect of TT with forward downhill walking (DW), forward uphill walking (UW), and forward walking with no incline (WWI) on balance, strength, flexibility, and gait parameters in 7-18-year-old children with hemiparetic and diparetic CP in addition to traditional physiotherapy applications.
Sixty-four participants were initially recruited in this study. However, 42 participants (18 female, 24 male) with hemiparetic and diparetic CP completed the study. The study was conducted in a Special Education and Rehabilitation Center in Denizli, Turkey between April 2021 and June 2022. The inclusion criteria for the study were (a) age between 7-18 yrs old, (b) being at Gross Motor Functional Classification System (GMFCS) levels II, (c) no cooperation problems that would interfere with communication, (d) no surgical treatment or neuromuscular injection in the last 6 months (e) no unstoppable epileptic seizures, (f) asymmetric lower extremity shortness >4 cm and no any health problems except CP. Exclusion criteria from the study were 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 All parents/guardians agreed to the participation of their children by signing a statement of informed consent. The investigation was approved by the Pamukkale University Clinical Research Ethics Committee (60116787-020-35801/24.03.2021). All procedures were realized in according to the Declaration of Helsinki.
To ensure that the gender and age distributions to be observed in the groups were similar, a randomization table was prepared by stratified randomization method before the study.
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 DW TT, the second group performed UW TT, and the third group performed WWI TT walking exercise on the treadmill for 2 days/week, 30 min/day on different days. At the beginning and end of the 8-week program, the participants' lower extremity isometric strength was assessed using a hand-held dynamometer, dynamic balance was assessed using a functional reach test (FRT), flexibility was assessed range of motion (ROM) using a goniometer, and gait performance was assessed using a spatiotemporal gait analyzer. All measurements included familiarization trials. Conventional physiotherapy program, walking exercises, and measurements were conducted in standard conditions (22-25 °C, 25%-45% relative humidity) during the morning hours in a quiet room by the same physiotherapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| downhill walking | Active comparator | Other: downhill walkingAll participants received a conventional physiotherapy program. In addition to this program, the first group performed downhill walking exercise on the treadmill |
| uphill walking | Active comparator | Other: uphill walkingAll participants received a conventional physiotherapy program. In addition to this program, the second group performed uphill walking exercise on the treadmill |
| walking with no incline | Active comparator | Other: walking with no inclineAll participants received a conventional physiotherapy program. In addition to this program, the third group performed walking with no incline exercise on the treadmill |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| downhill walkingAll 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. | Other | downhill walking |
| uphill walkingAll 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. | Other | uphill walking |
| walking with no inclineAll 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. | Other | walking with no incline |
Primary outcome
Balance
Time frame: 8 weeks
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.
Isometric muscle strength
Time frame: 8 weeks
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.
Flexibility
Time frame: 8 weeks
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.
Spatiotemporal gait analysis
Time frame: 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berna Ramanlı principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing downhill walking, uphill walking and walking with no incline in people with Cerebral Palsy, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.