NCT06667856

Brief Summary

The aim of this study was to investigate the effects of lower extremity exercises combined with foot core exercise training on lower extremity pain, foot functionality, static and dynamic parameters of gait, and postural stability in individuals with rheumatoid arthritis using synchronous and asynchronous telerehabilitation methods.

Trial Health

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Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
18

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
10mo left

Started Sep 2026

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

October 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 24, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

October 24, 2024

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Foot Posture Index

    It is a six-item index that determines foot posture. In this index, palpation of the distal talus medially and laterally, inequality in submalleolar and supramalleolar recesses, position of the calcaneus, medial protrusion of the navicular region in posterior observation, evaluation of the medial longitudinal arch, and the number of toes visible medially or laterally when viewed from the posterior will be evaluated. The examined regions are evaluated for each item up to (+2) according to the degree of pronation and up to (-2) according to the degree of supination, and the total score is obtained by summing these values.

    Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

  • Static Gait Analysis Evaluation

    The evaluation will be made in a position where individuals stand with their arms free at their sides, their eyes fixed on a point 3 meters away in front, maintaining their posture as much as possible. In the static posture evaluation, the load on the right and left feet, and the right-left contact surface data will be evaluated and recorded. This parameter will be evaluated with the MultiSensor Platform 160 × 40 baropodometer device.

    Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

  • Dynamic Gait Analysis Evaluation

    Individuals will be asked to walk at a speed they feel comfortable with, at least 8 steps on a 5-meter walking platform (3-meter platform and 2-meter walking analysis platform). The evaluation will be repeated 3 times. From the two-meter walking analysis 17 platform; left-right foot pressure percentage and left-right contact surfaces during walking will be obtained numerically and graphically. This parameter will be evaluated with the MultiSensor Platform 160 × 40 baropodometer device.

    Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

  • Postural Stability Assessment

    Individuals will be asked to place their feet on the soles before measurements are taken, and the foot position of the individuals will not change during static measurements. For static load distribution measurement and bipedal balance measurement, individuals will be asked to keep their arms free next to their bodies and maintain their posture as much as possible by fixing their eyes on a point 3 meters in front. The measurement will be made with and without support, with eyes open and closed for 60 seconds. This parameter will be evaluated with the MultiSensor Platform 160 × 40 baropodometer device.

    Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Secondary Outcomes (2)

  • Visual Analog Scale-Pain

    Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

  • Foot Function Index

    Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Study Arms (2)

Asynchronous telerehabilitation group

ACTIVE COMPARATOR
Other: Asynchronous exercise group

Synchronous telerehabilitation group

ACTIVE COMPARATOR
Other: Synchronous exercise group

Interventions

Application of foot core training combined with lower extremity exercises using asynchronous telerehabilitation method.

Asynchronous telerehabilitation group

Application of foot core training combined with lower extremity exercises using synchronous telerehabilitation method.

Synchronous telerehabilitation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having been diagnosed with rheumatoid arthritis
  • Being between the ages of 18-65
  • Being willing to participate in the study

You may not qualify if:

  • Having a neurological disease
  • Having a pulmonary or cardiovascular problem that may affect daily life activities
  • Sensory system disorders
  • Having a history of surgery on the lower extremities or trunk
  • Experiencing dizziness
  • Having a cognitive disorder
  • Having an additional rheumatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, RheumatoidMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

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
Researcher

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 31, 2024

Study Start (Estimated)

September 24, 2026

Primary Completion (Estimated)

May 24, 2027

Study Completion (Estimated)

July 24, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations