NCT06295107

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

February 28, 2024

Last Update Submit

July 24, 2025

Conditions

Keywords

Cerebral palsyChildrenpROMGoniometerSpasticityReliability

Outcome Measures

Primary Outcomes (2)

  • Ankle range of motion

    Goniometer measurements of ankle range of movement

    2023-2024

  • Knee range of motion

    Goniometer measurements of knee range of movement

    2023-2024

Study Arms (2)

Spastic leg

Children with spastic hemiplegic cerebral palsy.

Diagnostic Test: Ankle Passive Range of Movement (pROM)Diagnostic Test: Knee Passive Range of Movement (pROM)

Non spastic leg

Children with spastic hemiplegic cerebral palsy.

Diagnostic Test: Ankle Passive Range of Movement (pROM)Diagnostic Test: Knee Passive Range of Movement (pROM)

Interventions

Ankel and knee pROM measurements.

Non spastic legSpastic leg

Ankel and knee pROM measurements.

Non spastic legSpastic leg

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Habilitation Unit

Lund, Skåne County, 22241, Sweden

Location

Related Publications (11)

  • 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.

    PMID: 12089500BACKGROUND
  • 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.

    PMID: 3809245BACKGROUND
  • 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.

    PMID: 11245764BACKGROUND
  • 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.

    PMID: 23196790BACKGROUND
  • Gandbhir VN, Cunha B. Goniometer. 2020 Jun 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558985/

    PMID: 32644411BACKGROUND
  • 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.

    PMID: 30341552BACKGROUND
  • 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.

    PMID: 21740600BACKGROUND
  • 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.

    PMID: 22666642BACKGROUND
  • 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.

    PMID: 16291848BACKGROUND
  • 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.

    PMID: 10998607BACKGROUND
  • 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.

    PMID: 17108799BACKGROUND

Related Links

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gunnar Hägglund

    Lund University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant pediatric orthopedic surgeon

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 6, 2024

Study Start

October 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 29, 2025

Record last verified: 2025-07

Locations