- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05442944
Dynamic and Static Balance and the Speed of Reaction in the Elderly
Analysis of the Impact of Uncomplicated Physiotherapeutic Procedures on the Correlation of Static and Dynamic Balance and the Speed of Reaction in the Elderly - a Randomized Observational Study
The balance of the body in the elderly is disturbed for various reasons and relatively often.
The aim of our research was to analyze the effect of five simple physiotherapeutic procedures on the reaction speed as well as static and dynamic balance in the elderly.
60 people (women and men diagnosed with degenerative changes of the spine, chronic period of the disease) aged 65-95 years were analyzed. Patients were randomly assigned to the study group (30 people - participating in the three-week physiotherapy program) and the control group (30 people - not participating in the program). The test consisted in checking the state of static (postural stability) and dynamic (risk of falls) balance on the Biodex SD dynamic platform and the assessment of speed in the Timed Up-and-Go (TUG) test. The results of our research showed that five simple physiotherapy treatments can significantly improve the reaction speed and the dynamic and static balance in the sagittal plane in the elderly.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The balance of the human body is the result of a properly developed musculoskeletal system, an efficiently functioning nervous system and labyrinth, organs of deep feeling, and the organ of vision. The speed of reaction is an important factor in maintaining the body's balance and reduces the risk of falls, not only in the elderly.
The aim of the study is to analyze the influence of uncomplicated physiotherapeutic procedures on the reaction speed as well as static and dynamic balance in the elderly.
60 people (degenerative changes of the spine) in the chronic period of the disease were analyzed. Age of respondents: 65-95 years, women and men. Patients were randomly assigned to the study group (30 people - participating in the three-week physiotherapy program) and the control group (30 people - not participating in the program). The test consisted in checking the state of static (postural stability) and dynamic (risk of falls) balance on the Biodex SD dynamic platform. Additionally, each patient participated in the Timed Up-and-Go (TUG) test. In the study group, most of the studied variables, analyzed before and after rehabilitation, differed significantly (frontal plane inclinations p = 0.024; QuadsL p = 0.002; TUG p = 0.022). Significant differences were also noted between the groups after the end of the therapy (QuadsL 1 p = 0.015; PostL p = 0.011). Moreover, the correlation between TUG and anterior and lateral (p = 0.032) was confirmed. Conclusions: The use of simple physiotherapeutic procedures significantly improves the reaction speed as well as dynamic and static balance in the sagittal plane in the elderly. Improvement in sagittal static stability and deterioration in the coronal plane contribute to a reduction in TUG time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1) age over 65, 2) generalized degenerative disease, 3) osteoarthritis of the lumbar spine, 4) possibility of walking at least 6 meters without orthopedic support, 5) ability to stand up and sit on a chair independently.
Exclusion Criteria:
- 1) other than the required disease entity, 2) neurological diseases, labyrinth diseases, vascular imbalances, 3) use of psychotropic drugs, 4) cognitive disorders, 5) people who do not meet the requirements of the equipment used for measurements (weight over 136 kg, height under 130 cm, height over 178 cm), 6) high, low blood pressure, dizziness, malaise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A study group with physiotherapeutic intervention.
The study group - 30 people - participated in the three-week physiotherapy program.
|
As part of the rehabilitation program, the patients performed two exercises in the Universal Therapeutic Rehabilitation Room (UTRR) system.
The patient's task was to perform simultaneous abduction and adduction of the upper and lower limbs.
The duration of the procedure was 10 minutes, the patient performed the exercises at a comfortable pace.
In the second exercise - the patient's task was to alternately bend and straighten the opposite lower and upper limbs.
The duration of the exercise was 10 minutes.
The combined duration of both procedures used was 20 minutes.
In addition, each patient underwent three physical therapy treatments.
The procedures were carried out 5 days a week (Monday to Friday) for three weeks.
|
|
No Intervention: A Control group without physiotherapeutic intervention
The control group - 30 people - did not participate in the program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural stability - static balance on Biodex SD dynamic platform.
Time Frame: Before therapy
|
Postural stability was investigated by forward deflections in the sagittal plane.
|
Before therapy
|
|
Postural stability - static balance on Biodex SD dynamic platform.
Time Frame: Before therapy
|
Postural stability was investigated by backward deflections in the sagittal plane.
|
Before therapy
|
|
Postural stability - static balance on Biodex SD dynamic platform.
Time Frame: Before therapy
|
Postural stability was investigated sideways, in the frontal plane.
|
Before therapy
|
|
Postural stability - static balance on Biodex SD dynamic platform.
Time Frame: Before therapy
|
Postural stability was investigated by inward deflections in the frontal plane.
|
Before therapy
|
|
Risk of falls - dynamic balance on Biodex SD dynamic platform.
Time Frame: Before therapy
|
The evaluation of the dynamic equilibrium was carried out by measuring the mean deviations of the center of gravity of the subject (overall) on an unstable substrate, the lability of which varied with time, from a more stable state to unstable ground.
The Biodex SD platform has a twelve-point instability scale, where level 12 corresponds to a rigid and stable setting and level 1 to a hypermobility setting.
For the purposes of the study, levels from 8 to 4 were used.
|
Before therapy
|
|
Speed of reaction as measured by the functional Timed Up and Go (TUG) test.
Time Frame: Before therapy
|
The task of the subject during the test was, on the command "start" given by the examiner, to perform the following activities as soon as possible: get up from the chair, walk three meters straight, go around the cone, return the same way to the place, and sit on the chair again.
The investigator measured the time of all performed motor tasks from giving the command and starting them until returning to the chair.
|
Before therapy
|
|
Postural stability - static balance on Biodex SD dynamic platform.
Time Frame: Before therapy
|
Percent of the time spent by the center of body mass in individual quadrants of the platform.
|
Before therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural stability - static balance on Biodex SD dynamic platform.
Time Frame: After 3 weeks of therapy
|
Postural stability was investigated by forward deflections in the sagittal plane.
|
After 3 weeks of therapy
|
|
Postural stability- static balance on Biodex SD dynamic platform
Time Frame: 3 weeks after therapy
|
Postural stability was investigated by backward deflection in the sagittal plane
|
3 weeks after therapy
|
|
Postural stability - static balance on Biodex SD dynamic platform.
Time Frame: 3 weeks after therapy
|
Postural stability was investigated sideways, in the frontal plane.
|
3 weeks after therapy
|
|
Postural stability - static balance on Biodex SD dynamic platform.
Time Frame: 3 weeks after therapy
|
Postural stability was investigated by inward deflections in the frontal plane.
|
3 weeks after therapy
|
|
Risk of falls - dynamic balance on Biodex SD dynamic platform.
Time Frame: 3 weeks after therapy
|
The evaluation of the dynamic equilibrium was carried out by measuring the mean deviations of the center of gravity of the subject (overall) on an unstable substrate, the lability of which varied with time, from a more stable state to an unstable ground.
The Biodex SD platform has a twelve-point instability scale, where level 12 corresponds to a rigid and stable setting and level 1 to a hypermobility setting.
For the purposes of the study, levels from 8 to 4 were used.
|
3 weeks after therapy
|
|
Speed of reaction as measured by the functional Timed Up and Go (TUG) test.
Time Frame: 3 weeks after therapy
|
The task of the subject during the test was, on the command "start" given by the examiner, to perform the following activities as soon as possible: get up from the chair, walk three meters straight, go around the cone, return the same way to the place, and sit on the chair again.
The investigator measured the time of all performed motor tasks from giving the command and starting them until returning to the chair.
|
3 weeks after therapy
|
|
Postural stability - static balance on Biodex SD dynamic platform.
Time Frame: 3 weeks after therapy
|
Percent of the time spent by the center of body mass in individual quadrants of the platform.
|
3 weeks after therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Olczak, PhD, Rehabilitation Clinic, Military Institute of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9/KRN/2011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spondyloarthritis
-
University of BonnNovartis; Novartis PharmaceuticalsRecruitingAxial Spondyloarthritis | Axial and Peripheral Spondyloarthritis | Axial Spondyloarthopathy | Axial Spondyloarthritis and Ankylosing Spondylitis | Axial Spondyloarthritis (AxSpA) | Axial Spondylarthritis (r-axSpA) | Axial Spondyloarthritis, Non-RadiographicGermany
-
Lingli DongNot yet recruitingNon-Radiographical Axial Spondyloarthritis | Nr-axial SpondyloarthritisChina
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.RecruitingA Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial SpondyloarthritisActive Non-radiographic Axial SpondyloarthritisChina
-
UCB Biopharma SRLCompletedNonradiographic Axial SpondyloarthritisUnited States, Belgium, Bulgaria, China, Czechia, France, Germany, Hungary, Japan, Poland, Spain, United Kingdom, Turkey (Türkiye)
-
Sunshine Guojian Pharmaceutical (Shanghai) Co.,...Not yet recruitingAxial Spondyloarthritis, Non-RadiographicChina
-
Novartis PharmaceuticalsActive, not recruitingNon-radiographic Axial SpondyloarthritisItaly, Germany, Thailand, Israel, Belgium, France, Hungary, Malaysia, Poland, Philippines, Colombia, Mexico, Romania, Czechia, Brazil, Netherlands, Vietnam, Turkey (Türkiye)
-
Novartis PharmaceuticalsCompletedNon-radiographic Axial SpondyloarthritisChina
-
Sunshine Guojian Pharmaceutical (Shanghai) Co.,...RecruitingAxial SpondyloarthritisChina
-
Merck Sharp & Dohme LLCCompletedSpondyloarthritisCzechia, Germany, Netherlands, Poland, Romania, Russian Federation, Spain, Turkey, Ukraine
-
UCB Biopharma SRLActive, not recruitingAnkylosing Spondylitis | Axial Spondyloarthritis | r-axSpa | Nr-axSpaUnited States, Belgium, Bulgaria, China, Czechia, France, Germany, Hungary, Japan, Netherlands, Poland, Spain, United Kingdom, Turkey (Türkiye)
Clinical Trials on Physiotherapeutic procedures
-
University of Sao Paulo General HospitalCompleted
-
Klaudia Fabičovic, PTCompleted
-
University Hospital, Basel, SwitzerlandCompleted
-
Clínica de Hidroterapia e Recuperacao FuncionalIntegrated Faculty of RecifeTerminatedMorquio's Disease
-
University Hospital, Basel, SwitzerlandCompletedFear of FallingSwitzerland
-
Kuopio University HospitalCentral Finland Hospital DistrictTerminated
-
vandfysHerlev and Gentofte HospitalCompleted
-
Federal University of São PauloWithdrawnChronic Low Back PainBrazil
-
University of Sao PauloRecruitingEpisiotomy | Perineal Injury | Perineal Pain | Perineal Tear Resulting From Childbirth | Lacerations Perineal | Obstetric Anal Sphincter Injury | Perineal Tear and Episiotomy | Perineal Laceration, Tear, or Rupture During DeliveryBrazil
-
Xinhua Hospital, Shanghai Jiao Tong University...Xinhua Hospital Chongming Branch; Shanghai First Rehabilitation Hospital; Shanghai... and other collaboratorsUnknownScoliosis Idiopathic AdolescentChina