Influence of Hawthorne Effect and Dual-tasks on Gait in CP

NCT05417399 | Recruiting

• 1 other identifier: 2022-13822
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

It is the clinical experience of the authors that some children with cerebral palsy who walk in crouch gait show sufficient knee extension during the clinical gait analysis, but walk in considerable knee flexion when they leave the gait laboratory. Possible differences between walking in a gait lab and walking in daily life may be caused by the effect of observational awareness in the lab (also known as the Hawthorne effect), and the lack of dual-tasks (DT) during the analysis (which are common during daily life walking). Since so far there is no technique to reliably measure gait kinematics in children with CP outside of the laboratory, the researchers aim to objectify the influence of both the Hawthorne effect and dual-tasks by introducing different conditions during a standard clinical 3D gait analysis.

Conditions

Cerebral Palsy; Gait Disorders, Neurologic; Hawthorne Effect; Dual-tasks; Kinematics

Outcome Measures

Primary Outcomes (1)

• Minimal knee flexion during the single support phase

  Minimal knee flexion during the single support phase

  Day 1

Secondary Outcomes (8)

• Foot to floor angle at initial contact

  Day 1

• Knee flexion at initial contact

  Day 1

• Foot to floor angle at moment of minimal knee flexion in single support phase

  Day 1

• Variation of knee kinematics in stance phase

  Day 1

• Variation of ankle kinematics in stance phase

  Day 1

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All subjects are recruited from the patient base of Roessingh Center for Rehabilitation. Subjects will be included in the study when a clinical 3D gait analysis is due and the inclusion and exclusion criteria as mentioned are met.

You may qualify if:

• Cerebral palsy, bilateral spastic, GMFCS classification I-III
• Age \<16 years
• Use of bilateral AFO's (rigid or ground reaction AFO's) to improve knee extension in stance

You may not qualify if:

• Behavioural issues or poor instructability which might affect participation in the protocol
• Significant visual disorders
• Other diagnoses influencing gait

Sponsors & Collaborators

• Roessingh Research and Development: lead

Study Sites (1)

Roessingh Research and Development

Enschede, Overijssel, 7522AH, Netherlands

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans Rietman, Professor

  Roessingh Research and Development

  STUDY CHAIR

Central Study Contacts

Martin Oude Alink, Msc

CONTACT

0031534875454; m.oudealink@roessingh.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: September 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)