NCT06988631

Brief Summary

This study is the first to examine the effect of sole sensory training on sensorimotor organization in individuals with GEH. Individuals with a Beighton score of 5 and above were included in the study. Within the scope of the study, individuals with general joint hypermobility (GEH) were divided into intervention and control groups by the Randomization method. The intervention group received sole sensory training in the home environment. Both groups were given a foot care brochure. The individuals' sole sensory and balance skills were evaluated before and after the intervention. As a result of the study, the intervention aimed to prevent injuries and disabilities that may occur due to joint laxity by improving sole sensory and balance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

May 16, 2025

Last Update Submit

May 16, 2025

Conditions

Keywords

joint hypermobilityfood senseSensorimotor

Outcome Measures

Primary Outcomes (3)

  • Light touch sensation

    It was evaluated using the Semmes-Weinstein Monofilament (SWM) test kit.

    2 weeks

  • Two-Point Separation sensation

    A discriminator was used to assess two-point discrimination perception.

    2 weeks

  • Vibration sense

    A 128 Hz tuning fork was used to evaluate vibration sensation.

    2 weeks

Secondary Outcomes (3)

  • Proprioception

    2 weeks

  • Muscle Strength

    2 weeks

  • Balance

    2 weeks

Study Arms (2)

Kontrol group

ACTIVE COMPARATOR

Participants were given brochures and training on foot care and health.

Other: foot care booklet

exercise group

EXPERIMENTAL

Participants were asked to practice the foot sole sensory training program at home every day for 2 weeks.

Other: Sensory treatment

Interventions

Participants were asked to practice the foot sole sensory training program at home every day for 2 weeks.

exercise group

Participants were given a booklet about healthy feet and were informed.

Kontrol group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Persons with a Beighton score ≥5 without any systemic disease
  • Asymptomatic persons

You may not qualify if:

  • People who have had an upper or lower extremity injury in the last 3 months,
  • People who have a history of fractures or surgery in the last year,
  • People who have been pregnant in the last year,
  • Those diagnosed with Ehlers-Danlos Syndrome (EDS), hypermobile Ehlers-Danlos syndrome (hEDS), or hypermobility spectrum disorders (HSD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum technical university

Erzurum, State/Province, 25200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2025

First Posted

May 25, 2025

Study Start

January 15, 2024

Primary Completion

November 15, 2024

Study Completion

December 15, 2024

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations