CClinicalTrials.gg
Not yet recruitingNCT05973279Updated Sep 7, 2023

The Relationship Between Lower Limb Functionality, Knee Joint Position Sense, Balance and Falls in Haemiplegic Patients

An observational study in Haemiplegic Patients, Balance and Knee Joint Position Sensation, sponsored by Karabuk University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Karabuk University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
60
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Stroke is defined as a neurological disorder attributed to acute focal damage of the central nervous system from a vascular cause, including cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. The World Health Organisation defines stroke as a focal and sometimes global impairment of cerebral function that lasts longer than 24 hours or ends in death, develops rapidly, has no demonstrable cause other than a vascular cause. Evaluation of muscle strength and balance ability of affected patients is critical for the recovery of lower extremity motor functions.

Proprioception encompasses various sensory perception modalities such as force, effort, movement and limb position. Impairment of sensory function in patients with haemiplegia can hinder the ability of muscles to recover during walking. Accurate and effective assessment of gait and balance functions and their subsequent improvement is one of the primary goals of stroke rehabilitation programmes. Studies comparing the effects of lower extremity functionality and knee joint position sense on balance and falls are available in various versions in the literature. However, there is no study in which 'Restorative Therapies RT300 leg/arm/cor' device was used to measure functionality, 'Humac Norm Isokinetic Machine' was used to measure knee joint position sense, and 'Tecno Body Prokin Isokinetic Balance System' was used to measure balance in a single simultaneous study. Therefore, the aim of this study was to investigate the relationship between lower limb functionality and knee joint position sense with balance and fall parameters in patients with hemiplegia using various devices.

02

Conditions studied

  • Haemiplegic Patients
  • Balance
  • Knee Joint Position Sensation
  • Lower Limb Functionality

Keywords

  • Proprioception
  • Joint Position Sense
  • Hemiplegia
  • Lower Limb Functionality
  • Balance
  • Fall
03

In context

Lead sponsor

Karabuk University is the lead sponsor of 126 studies on the registry; 30 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hemiplegic patients

Inclusion criteria

  • Individuals over 18 years of age
  • Volunteering to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Hip and knee prosthesis
  • Being diagnosed with vertigo
  • Having a history of serious neurological diseases such as Parkinson's disease, multiple sclerosis except hemiplegia
  • Having a previous operation for the lower limb
  • Poor co-operation
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
60 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Hemiplegic patients

    Other: Tecno Body Prokin Isokinetic Balance System · Other: Restorative Therapies RT300 leg/arm/cor: · Other: CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System

Interventions

  • OtherTecno Body Prokin Isokinetic Balance System

    It provides objectively measurable data in static and dynamic balance measurements. The moving balance platform of the system, which is driven by air piston servo motors, can measure at a working angle of 15 degrees in all directions. The results can be monitored and recorded live on the screen on the device. From these data, each individual's static and dynamic balance score is obtained by summing the forward-backward standard deviation and right-left standard deviation.

  • OtherRestorative Therapies RT300 leg/arm/cor:

    RT300 is a motorised treatment system. In general there are 3 systems; Passive therapy, Active therapy and a combination of active therapy with some assistance from the motor. The device can be used from a chair, wheelchair or bed and there are two variants that can be used separately; Leg system, Arm system. Electrodes placed on the skin over specific muscle groups are connected via a cable or wirelessly to the RT300. These are used to stimulate peripheral motor nerves, causing the muscles to work. The software of the SAGE controller unit of the RT300 monitors the treatment process, including the stimulation patterns sent to the arms or legs, and the operation of the ergometer motor to produce smooth cycling motion. Contraindicated in the presence of lower limb fractures or pregnancy.

  • OtherCSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System

    22 isolated joint movement models, 4 resistance modes (isokinetic, isotonic, isometric and passive) and a large number of reports to meet the measurement and exercise needs of today's clinicians and researchers. The exercise modes of the device include; Continuous passive movement, multi-angle isometry, proprioception training, standard and eccentric focused isokinetic strengthening, deceleration training, dynamic isotonic training, strength training. Test modes of the device include; Proprioceptive, co-measured, standard isokinetic, concentric/eccentric isokinetic, intermittent stroke isokinetic test.

06

What researchers measure

Primary outcomes

  1. Balance and knee joint position

    Knee joint position sense is related to balance in haemiplegic patients.

    Time frame: First day

  2. Lower extremity functionality and balance

    In haemiplegic patients, the level of lower extremity functionality is related to balance.

    Time frame: First day

  3. Falling and knee joint position

    Knee joint position sense is associated with falls in haemiplegic patients.

    Time frame: First day

  4. Lower extremity functionality and falling

    Lower extremity functionality is associated with falls in haemiplegic patients.

    Time frame: First day

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05973279
Lead sponsor
Karabuk University
Collaborators
Bolu Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
Responsible party
Fatma Hale Altınkaya (INVESTIGATOR, Karabuk University) — Principal investigator
First posted
Aug 2, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Oct 1, 2023 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Sep 7, 2023

Study contacts

Fatma Hale Altınkaya
Contact
f.hale.altinkaya@gmail.com
05312013899
Tarık Ozmen
Contact
tarikozmen@karabuk.edu.tr
05063028740
Adnan Demirel
study director · Izzet Baysal Physiotherapy and Rehabilitation Training and Research 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 not yet recruiting, as verified in Sep 2023. 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