NCT05442944

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

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

March 2, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2012

Completed
10.3 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
Last Updated

January 27, 2026

Status Verified

June 1, 2022

Enrollment Period

10 months

First QC Date

June 22, 2022

Last Update Submit

January 25, 2026

Conditions

Keywords

elderly,physiotherapy,static balance,dynamic balance,reaction speed,risk of falls

Outcome Measures

Primary Outcomes (7)

  • Postural stability - static balance on Biodex SD dynamic platform.

    Postural stability was investigated by forward deflections in the sagittal plane.

    Before therapy

  • Postural stability - static balance on Biodex SD dynamic platform.

    Postural stability was investigated by backward deflections in the sagittal plane.

    Before therapy

  • Postural stability - static balance on Biodex SD dynamic platform.

    Postural stability was investigated sideways, in the frontal plane.

    Before therapy

  • Postural stability - static balance on Biodex SD dynamic platform.

    Postural stability was investigated by inward deflections in the frontal plane.

    Before therapy

  • Risk of falls - dynamic balance on Biodex SD dynamic platform.

    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.

    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.

    Percent of the time spent by the center of body mass in individual quadrants of the platform.

    Before therapy

Secondary Outcomes (7)

  • Postural stability - static balance on Biodex SD dynamic platform.

    After 3 weeks of therapy

  • Postural stability- static balance on Biodex SD dynamic platform

    3 weeks after therapy

  • Postural stability - static balance on Biodex SD dynamic platform.

    3 weeks after therapy

  • Postural stability - static balance on Biodex SD dynamic platform.

    3 weeks after therapy

  • Risk of falls - dynamic balance on Biodex SD dynamic platform.

    3 weeks after therapy

  • +2 more secondary outcomes

Study Arms (2)

A study group with physiotherapeutic intervention.

EXPERIMENTAL

The study group - 30 people - participated in the three-week physiotherapy program.

Procedure: Physiotherapeutic procedures

A Control group without physiotherapeutic intervention

NO INTERVENTION

The control group - 30 people - did not participate in the program.

Interventions

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.

A study group with physiotherapeutic intervention.

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \) 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.

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Officials

  • Anna Olczak, PhD

    Rehabilitation Clinic, Military Institute of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 5, 2022

Study Start

March 2, 2011

Primary Completion

December 15, 2011

Study Completion

March 14, 2012

Last Updated

January 27, 2026

Record last verified: 2022-06