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

Balance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05973279
• Other study ID #: KarabukUNI
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: September 2023
• Source: Karabuk University
• Contact: Fatma Hale Altinkaya
• Phone: 05312013899
• Email: f.hale.altinkaya[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Individuals over 18 years of age

• Volunteering to participate in the study

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

Related Conditions & MeSH terms

• Balance

Intervention

Other:
• Tecno 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.
• Restorative 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.
• CSMI (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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karabuk University	Bolu Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance and knee joint position	Knee joint position sense is related to balance in haemiplegic patients.	First day
Primary	Lower extremity functionality and balance	In haemiplegic patients, the level of lower extremity functionality is related to balance.	First day
Primary	Falling and knee joint position	Knee joint position sense is associated with falls in haemiplegic patients.	First day
Primary	Lower extremity functionality and falling	Lower extremity functionality is associated with falls in haemiplegic patients.	First day