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Cerebral PalsyNCT06295107

Reliability of Range of Movement Measurements in Cerebral Palsy

An observational study of Cerebral Palsy and Movement Disorders in Children, run by Region Skane at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim is to investigate the inter-rater reliability of passive range of motion (pROM) measurement with goniometer of knee extension and ankle dorsiflexion for children with unilateral spastic cerebral palsy (USCP) and secondary to explore to what extent spasticity influences the reliability. Read more about this study

Who is it for?
Ages 2 to 17 years
What is being tested?
Ankle Passive Range of Movement (pROM) and Knee Passive Range of Movement (pROM)
How many people
32 participants
Where
1 siteSweden
Study dates
1 Oct 2023to 31 Dec 2023
Phase
Observational
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 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children with with hemiplegic spastic cerebral palsy in the south of Sweden, Skane county.

Inclusion Criteria: Children with hemiplegic spastic cerebral palsy -

Exclusion Criteria: Other cerebral palsy diagnoses. Surgery or botulinum toxin treatment within 3 month prior to examination.

-

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Children Habilitation Unit

    Lund, Skåne County, 22241

Other trials in Sweden

About this study

Official title: The Influence of Spasticity on Reliability of Range of Movement Measurements for Knee and Ankle in a Pediatric Population With Cerebral Palsy

The aim is to investigate the inter-rater reliability of passive range of motion (pROM) measurement with goniometer of knee extension and ankle dorsiflexion for children with unilateral spastic cerebral palsy (USCP) and secondary to explore to what extent spasticity influences the reliability.

Read the detailed description

Scientific question The aim is to investigate the inter-rater reliability of passive range of motion (pROM) measurement with goniometer of knee extension and ankle dorsiflexion for children with unilateral spastic cerebral palsy (USCP) and secondary to explore to what extent spasticity influences the reliability.

Overview of the field Evaluating joint mobility is commonly used and important for physicians and physiotherapists assessing and treating children with cerebral palsy, to early detect occurrence of joint contracture. The primarily used method to measure joint pROM is to use a manual goniometer, even if techniques using a smartphone or other electronic device has been demonstrated (Herrero et al. 2011, Ferriero et al. 2013, Hancock et al. 2018). Previous studies indicate that traditional goniometry is usually reliable both for ankle and knee both in individuals with and without spastic muscles (Brosseau et al. 2001, Allington et al. 2002, McWhirk et al. 2006, Konor et al. 2012) even if some authors indicate that there is a considerable variability among children with spasticity (McDowell et al. 2000).

To our knowledge no earlier study has investigated children with hemiplegic cerebral palsy to evaluate the influence of spasticity on pROM measurements. The idea is to use the child as its own control having both a spastic and a non spastic limb.

Project description

Participants Almost all children with cerebral palsy in Sweden are linked to a local habilitation unit where regular assessments are made by the child's physiotherapist. Information from the national quality registry and follow-up program for individuals with cerebral palsy (CPUP) indicates that there are approximately 140 children with unilateral spastic cerebral palsy (USCP) in Skåne. Families and children (age 2 - 17 years) with USCP linked to habilitation units in Skåne will be asked to participate in the study trough written letter and/or by phone call. When applicable this will be part of the child´s regular and planned assessment. Children with other diagnoses than USCP will be excluded. Children with surgery on the lower extremity within the last year or botox administration to the lower extremity within the last 3 month will also be excluded.

Methods The child will be assessed during one session of around 30-60 min. ROM measurements of knee extension and ankle dorsiflexion will be made on each child's both legs by two investigators with a standard two axis goniometer used in regular practice. The goniometer consists of two 20 cm arms attached in one end by a node and with a grade scale. The CPUP manual describes standardized patient positions and goniometer arm position for ROM in different joints.

For popliteal angle the child is positioned supine with the measured legs hip flexed to 90 degree while the other leg is fixed in extended position. The node of the goniometer is positioned lateral over the knee joint, the fixed arm aligned with femur and pointing towards the greater trochanter, the moving arm is held parallel to the anterior margin of tibia and pointing to the lateral malleolus.

Knee extension is examined with the child in supine position and extended knee, the node of the goniometer is positioned lateral over the knee joint center of rotation, the fixed arm aligned with femur and pointing towards the greater trochanter, the moving arm is held parallel to the anterior margin of tibia and pointing to the lateral malleolus. Knee extension deficit is noted as a negative value.

ROM for the ankle joint is measured with extended knee. The child is positioned in supine position. The subtalar joint is stabilized by the examinator fixating the calcaneus. The intertarsal movement is inhibited by slightly inverting the forefoot. The fixed arm of the goniometer will be parallel to the anterior margin of the tibia and the moving arm parallel to the lateral margin of the foot. 90 degree in the ankle will be noted as 0 degree. Dorsal flexion less than 0 degree will be noted as a negative value.

The two investigators will do measurements separate and blinded from each other. Data including age, sex, spastic side (right/left), Gross Motor Classification System level (GMFCS), use of orthosis and level of spasticity according to Ashworth. Level of spasticity on the spastic side will be a consensus decision by the two investigators.

Statistics Statistical power analyses calculations imply that the planned study need at least 32 children to examine 64 legs. Inter-rater reliability will be evaluated using Intra-class correlation coefficient (ICC). Limits of agreement analysis will also be used. Effect of spasticity on the reliability of pROM measurement will be evaluated comparing the ICC on the spastic leg to the non spastic leg.

Ethics The risk of causing physical harm to the research participants is considered very low. Evaluating pROM is part of regular assessment of these children. The time consumed by participating in the study might be extra compared to normal follow up but is very limited and proportional to valuable information that might be the result of the study. To minimize the pressure on families to participate, families under treatment from the researchers will primarily not be approached. Data collected will be stored in a safe way on encrypted hard drive. Personal numbers will be replaced by serial numbers and only the main researcher will have the code key.

Importance The risk of joint contracture is a major cause for concern in the growing child with cerebral palsy and something that is closely monitored by physicians and physiotherapists. Delayed diagnosis of joint contracture often leads to surgical release, a last option of treatment. The main tool for monitoring is by ROM measurements on a regular basis. Early detection of a decreasing ROM is vital for successful treatment and optimal outcome over time. The current study will add further knowledge on how ROM measurements can be interpreted and so hopefully lead to improved care for this group of children. The results will also be of importance to the research field for planning future studies and interpreting results.

Being tested
Ankle Passive Range of Movement (pROM), Knee Passive Range of Movement (pROM)
Keywords
Cerebral palsy, Children, pROM, Goniometer, Spasticity, Reliability
Medical subject headings
Cerebral Palsy, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ankle Passive Range of Movement (pROM)Diagnostic test

    Ankel and knee pROM measurements.

  • Knee Passive Range of Movement (pROM)Diagnostic test

    Ankel and knee pROM measurements.

Study groups in NCT06295107
Study groupRoleWhat they receive
Spastic legChildren with spastic hemiplegic cerebral palsy.
Receives: Diagnostic Test: Ankle Passive Range of Movement (pROM); Diagnostic Test: Knee Passive Range of Movement (pROM)
Non spastic legChildren with spastic hemiplegic cerebral palsy.
Receives: Diagnostic Test: Ankle Passive Range of Movement (pROM); Diagnostic Test: Knee Passive Range of Movement (pROM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ankle range of motion

    Goniometer measurements of ankle range of movement

    Measured: 2023-2024

  2. Knee range of motion

    Goniometer measurements of knee range of movement

    Measured: 2023-2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start1 Oct 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06295107
Sponsor's protocol ID
2023-00195-01
Other IDs
2023
Status last verified
Jul 2025
First submitted
28 Feb 2024
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Allington NJ, Leroy N, Doneux C. Ankle joint range of motion measurements in spastic cerebral palsy children: intraobserver and interobserver reliability and reproducibility of goniometry and visual estimation. J Pediatr Orthop B. 2002 Jul;11(3):236-9. doi: 10.1097/00009957-200207000-00007.

    PubMed 12089500
  • Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

    PubMed 3809245
  • Brosseau L, Balmer S, Tousignant M, O'Sullivan JP, Goudreault C, Goudreault M, Gringras S. Intra- and intertester reliability and criterion validity of the parallelogram and universal goniometers for measuring maximum active knee flexion and extension of patients with knee restrictions. Arch Phys Med Rehabil. 2001 Mar;82(3):396-402. doi: 10.1053/apmr.2001.19250.

    PubMed 11245764
  • Ferriero G, Vercelli S, Sartorio F, Munoz Lasa S, Ilieva E, Brigatti E, Ruella C, Foti C. Reliability of a smartphone-based goniometer for knee joint goniometry. Int J Rehabil Res. 2013 Jun;36(2):146-51. doi: 10.1097/MRR.0b013e32835b8269.

    PubMed 23196790
  • Gandbhir VN, Cunha B. Goniometer. 2020 Jun 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558985/

    PubMed 32644411
  • Hancock GE, Hepworth T, Wembridge K. Accuracy and reliability of knee goniometry methods. J Exp Orthop. 2018 Oct 19;5(1):46. doi: 10.1186/s40634-018-0161-5.

    PubMed 30341552
  • Herrero P, Carrera P, Garcia E, Gomez-Trullen EM, Olivan-Blazquez B. Reliability of goniometric measurements in children with cerebral palsy: a comparative analysis of universal goniometer and electronic inclinometer. A pilot study. BMC Musculoskelet Disord. 2011 Jul 10;12:155. doi: 10.1186/1471-2474-12-155.

    PubMed 21740600
  • Konor MM, Morton S, Eckerson JM, Grindstaff TL. Reliability of three measures of ankle dorsiflexion range of motion. Int J Sports Phys Ther. 2012 Jun;7(3):279-87.

    PubMed 22666642
  • Martin RL, McPoil TG. Reliability of ankle goniometric measurements: a literature review. J Am Podiatr Med Assoc. 2005 Nov-Dec;95(6):564-72. doi: 10.7547/0950564.

    PubMed 16291848
  • McDowell BC, Hewitt V, Nurse A, Weston T, Baker R. The variability of goniometric measurements in ambulatory children with spastic cerebral palsy. Gait Posture. 2000 Oct;12(2):114-21. doi: 10.1016/s0966-6362(00)00068-0.

    PubMed 10998607
  • McWhirk LB, Glanzman AM. Within-session inter-rater realiability of goniometric measures in patients with spastic cerebral palsy. Pediatr Phys Ther. 2006 Winter;18(4):262-5. doi: 10.1097/01.pep.0000234960.88761.97.

    PubMed 17108799

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy and Movement Disorders in Children, run by Region Skane at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 29 Jul 2025. 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 Sweden. 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?

Ankle range of motion (time frame: 2023-2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06295107, which also lists 11 linked publications.

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 29 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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