ClinicalTrials.gg
CompletedNCT07924748Updated Nov 9, 2026

Balance Training and Resting Brain Activity in Knee Osteoarthritis: A Randomized Controlled Trial

An interventional study of Conventional Rehabilitation (Muscle-Strengthening Training) and Standardized Balance Training in Osteoarthritis, Knee, sponsored by Qingdao Municipal Hospital. Completed at 1 site in China. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Qingdao Municipal Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2026, registered Nov 2026).
Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if a 8-week balance training program helps older adults with knee osteoarthritis (KOA) stand and walk more steadily and lowers their chance of falling. KOA is a common joint condition that causes knee pain and makes it hard to keep steady. The study will also look at how this training changes brain activity related to balance.

The main questions it aims to answer are:

  • Does balance training help people with KOA stand and walk more steadily?
  • Does it ease knee pain and make daily activities easier?
  • Does it change brain activity while the brain is at rest?

Researchers will compare two groups:

  • The balance training group will do muscle-strengthening exercises plus balance exercises.
  • The usual care group will do muscle-strengthening exercises only.

About 74 people will join the study. They will be placed in one of the two groups by chance, with about 37 people in each group. The staff who run the tests and analyze the results will not know which group a participant is in.

Participants will:

  • Attend exercise sessions 3 times a week for 8 weeks.
  • Do simple balance tasks, such as standing on one leg and walking around obstacles.
  • Answer questions about pain, stiffness, and daily activities before and after the 8 weeks.
  • Do short walking and balance tests, including the Timed Up and Go test, which measures how fast you can stand up, walk 3 meters, and sit back down. A shorter time means better mobility.
  • Stand on a special floor plate that records how much the body sways.
  • Have a resting brain scan called functional magnetic resonance imaging (fMRI), which measures brain activity while you lie still.

After the study ends, people in the usual care group who want to will also be offered the same balance training.

02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's enrollment of 74 is close to the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Qingdao Municipal Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Meets the diagnostic criteria for knee osteoarthritis according to the 2018 Chinese guidelines, with Kellgren-Lawrence radiographic grade 1 to 3.
  2. Aged 50 to 75 years.
  3. No severe cognitive or speech impairment; able to cooperate with all assessments and treatment.
  4. Not in the acute phase of pain; Visual Analogue Scale (VAS) score less than 6.
  5. Baseline Timed Up and Go (TUG) time of 13.5 seconds or more, indicating impaired dynamic balance and increased fall risk.
  6. Has not received other medication or treatment for the knee within the past 2 weeks.
  7. Willing to participate and provide signed .

Exclusion criteria

Exclusion Criteria:

  1. Severe cardiac, pulmonary, hepatic, renal, or endocrine disease, vestibular dysfunction, or psychiatric disease.
  2. Other inflammatory joint diseases (e.g., rheumatoid arthritis, gouty arthritis), or a history of major lower-limb surgery or fracture.
  3. to MRI, such as a cardiac pacemaker, aneurysm clips, metallic implants, or claustrophobia.
  4. Participation in other systematic rehabilitation training or interventional clinical research within the past 3 months.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Balance Training Group

    Participants will receive the same conventional rehabilitation as the control group-muscle-strengthening exercises including seated isotonic quadriceps training and side-lying hip abductor training, performed 3 times per week for 8 weeks-plus a standardized 8-week balance training program delivered 3 times per week, 40-45 minutes per session. The balance program progresses through three stages: (1) adaptation, covering basic agility, static balance on a foam pad, and anti-perturbation tasks with therapist assistance; (2) strengthening, progressing to more demanding static and dynamic balance, reactive, and sensory-integration tasks with reduced assistance; and (3) application, including obstacle courses, high-demand static and dynamic balance tasks, and cognitive dual-task exercises such as catching and throwing a ball.

    Behavioral: Conventional Rehabilitation (Muscle-Strengthening Training) · Behavioral: Standardized Balance Training

  • Active comparator
    Conventional Rehabilitation Group

    Participants will receive conventional rehabilitation only, consisting of muscle-strengthening exercises performed 3 times per week for 8 weeks. Training includes seated isotonic quadriceps strengthening and side-lying hip abductor strengthening using ankle sandbags; each contraction is held for 10 seconds and repeated in 3 sets of 10 repetitions. No additional balance training will be provided during the 8-week period.

    Behavioral: Conventional Rehabilitation (Muscle-Strengthening Training)

Interventions

  • BehavioralConventional Rehabilitation (Muscle-Strengthening Training)

    A 8-week conventional rehabilitation program consisting of muscle-strengthening exercises performed 3 times per week. It includes: (1) seated isotonic quadriceps training with an ankle sandbag, extending the knee to the maximum and holding for 10 seconds, 10 repetitions in 3 sets; and (2) side-lying hip abductor training with an ankle sandbag, abducting the hip to 30 degrees and holding for 10 seconds, 10 repetitions in 3 sets, with a 2-minute rest between sets.

  • BehavioralStandardized Balance Training

    A 8-week standardized balance training program delivered 3 times per week, 40-45 minutes per session, provided in addition to conventional rehabilitation. It progresses through three stages: (1) adaptation: basic agility such as cross-stepping, static balance on a foam pad (single-leg stance), and dynamic balance tasks with close therapist assistance; (2) strengthening: higher-difficulty static balance with reduced assistance, dynamic and reactive balance, and anti-perturbation and sensory-integration training; and (3) application: obstacle courses, high-demand static and dynamic balance tasks, and cognitive dual-task exercises such as catching and throwing a ball.

06

What researchers measure

Primary outcomes

  1. Timed Up and Go Test(TUG)

    The time in seconds required to rise from an armchair (about 45 cm high), walk 3 meters at a normal pace, turn around, walk back, and sit down. A shorter time indicates better functional mobility and dynamic balance.

    Time frame: Baseline and after 8 weeks of intervention

Secondary outcomes

  1. Berg Balance Scale (BBS)

    A 14-item standardized measure of static and dynamic balance; each item is scored 0-4, with a total score of 0-56. Higher scores indicate better balance.

    Time frame: Baseline and after 8 weeks of intervention

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    A 24-item questionnaire covering pain, stiffness, and physical function. Higher scores indicate worse symptoms and greater functional limitation.

    Time frame: Baseline and after 8 weeks of intervention

  3. Visual Analogue Scale (VAS)

    A 0-10 scale for knee pain intensity, where 0 means no pain and 10 means the worst imaginable pain.

    Time frame: Baseline and after 8 weeks of intervention

  4. Computerized Static Posturography

    Objective balance measures from a force plate, including plantar pressure distribution (load percentage across foot regions) and center-of-gravity sway angular velocity (deg/sec) during single-leg stance with eyes open and closed. Lower sway velocity indicates better postural stability.

    Time frame: Baseline and after 8 weeks of intervention

  5. Resting-State Functional Magnetic Resonance Imaging (rs-fMRI)

    Brain imaging measures of spontaneous neural activity and functional connectivity, including amplitude of low-frequency fluctuation (ALFF), regional homogeneity (ReHo), and functional connectivity (FC), used to assess balance-related brain function.

    Time frame: Baseline and after 8 weeks of intervention

Other outcomes

  1. Incidence of Adverse Events

    Any study-related adverse events, including muscle soreness, fatigue, falls, and MRI-related anxiety or discomfort, with severity and causal relationship documented.

    Time frame: Throughout the 8-week intervention period

07

Study locations

1 site
  • Qingdao Municipal Hospital
    Qingdao, Shandong 266071, China
08

References and documents

Publications

  • Diracoglu D, Aydin R, Baskent A, Celik A. Effects of kinesthesia and balance exercises in knee osteoarthritis. J Clin Rheumatol. 2005 Dec;11(6):303-10. doi: 10.1097/01.rhu.0000191213.37853.3d. PubMed 16371799 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07924748
Lead sponsor
Qingdao Municipal Hospital
Responsible party
Yao Zhao (Rehabilitation Therapist, Qingdao Municipal Hospital) — Principal investigator
First posted
Nov 9, 2026
Start date
Apr 1, 2026
Primary completion
Aug 1, 2026
Completion
Sep 1, 2026
Last update
Nov 9, 2026

Study contacts

Yao Zhao
principal investigator · Qingdao Municipal Hospital
Xintong Li
study director · Qingdao Municipal Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion