NCT07887802

Brief Summary

This study aimed to investigate the relationship between instrumented balance measurements and clinical balance assessments in individuals with Parkinson's disease and to evaluate changes in balance and functional mobility following a 12-week multimodal rehabilitation program. Eighteen individuals with Parkinson's disease participated in this prospective, single-group study. All participants received a rehabilitation program that included balance exercises, aerobic exercise, and balance training using the Korebalance system. The program was conducted twice weekly for 12 weeks. Balance was assessed using the Korebalance system and the Berg Balance Scale (BBS). Functional mobility was evaluated using the Timed Up and Go (TUG) test. Assessments were performed before and after the rehabilitation program. The study examined whether instrumented balance measurements were associated with clinical balance performance and whether balance and functional mobility changed following rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

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

February 5, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

2.5 years

First QC Date

October 15, 2026

Last Update Submit

October 15, 2026

Conditions

Keywords

Parkinson's DiseaseBalance RehabilitationKorebalanceInstrumented Balance AssessmentBerg Balance ScaleTimed Up and GoMultimodal RehabilitationPostural Stability

Outcome Measures

Primary Outcomes (2)

  • Change in Static Korebalance Score

    Static balance was assessed using the Korebalance Premiere-19 system. Measurements were obtained at baseline and after the 12-week multimodal rehabilitation program. Lower scores indicate better balance performance. Change was calculated as the post-intervention score minus the baseline score.

    Baseline and Week 12

  • Change in Dynamic Korebalance Score

    Dynamic balance was assessed using the Korebalance Premiere-19 system. Measurements were obtained at baseline and after the 12-week multimodal rehabilitation program. Lower scores indicate better balance performance. Change was calculated as the post-intervention score minus the baseline score.

    Baseline and Week 12

Secondary Outcomes (2)

  • Change in Berg Balance Scale Score

    Baseline and Week 12

  • Change in Timed Up and Go Test Time

    Baseline and Week 12

Study Arms (1)

Multimodal Rehabilitation Group

EXPERIMENTAL

Participants with Parkinson's disease received a 12-week supervised multimodal rehabilitation program, conducted twice weekly. The intervention included progressive balance exercises, functional mobility training, dual-task activities, moderate-intensity aerobic exercise, and Korebalance-assisted balance training. All participants received the same intervention, with no control group.

Behavioral: Multimodal Rehabilitation Program

Interventions

Participants received a supervised multimodal rehabilitation program twice weekly for 12 weeks (24 sessions). The program included approximately 10 minutes of warm-up exercises, 20 minutes of progressive balance training, and 20 minutes of moderate-intensity aerobic exercise using a treadmill or stationary bicycle. Balance exercises included static and dynamic balance tasks, multidirectional stepping, functional mobility activities, turning, and dual-task training. Additional balance training was performed using the Korebalance Premiere-19 system. Exercise intensity was generally maintained at a Borg Rating of Perceived Exertion of 11-14. Exercises were individually progressed according to participant ability and safety.

Multimodal Rehabilitation Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older.
  • Diagnosis of Parkinson's disease.
  • Hoehn and Yahr stages 1-3.
  • Sufficient cognitive function to understand and follow instructions during assessments and rehabilitation.
  • Ability to participate in the rehabilitation program.
  • Provision of written informed consent.

You may not qualify if:

  • Advanced Parkinson's disease (Hoehn and Yahr stages 4-5).
  • Significant cognitive impairment that could interfere with participation or assessment.
  • Other neurological disorders affecting balance or mobility.
  • History of surgery within the preceding six months.
  • Severe or uncontrolled systemic diseases that could interfere with safe participation in the rehabilitation program.
  • Refusal or inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A prospective, single-center, single-group pre-post interventional study. All participants received the same 12-week multimodal rehabilitation program. Outcomes were assessed at baseline and following completion of the intervention. No control group was included.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cihat Kurt, MD

Study Record Dates

First Submitted

October 15, 2026

First Posted

October 21, 2026

Study Start

February 5, 2024

Primary Completion

August 17, 2026

Study Completion

August 17, 2026

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations