Implementation and Validation of Instrumented Stair Climb Test
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-80
SponsorIRCCS Eugenio Medea
About this trial
The aim of this study is to design an instrumented test for the evaluation of the climb of stairs. In particular, the main purpose is to characterize and compare the performance of subjects, both pediatrics and adults, with different pathologies (cerebral palsy, amputee, Parkinson's disease, stroke and arthroplasty) in carrying out the instrumented test of climbing and descending stairs. This would provide potentially useful information to complement the clinical assessment, including investigating the existence of correlations between the instrumental data obtained and the clinical scales collected. The secondary objective is to evaluate, in a first phase of the study, the feasibility and reliability of the test, analyzing the validity of the indices obtained in terms of intra- and inter-operator reliability on healthy subjects.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Need for help from an operator or use of orthoses to make the stairs;
Inability to dress the instrumentation (accelerometer/electromyograph);
clinical condition that does not recommend the execution of scales (e.g. NYHA Class IV cardiovascular decompensation, epilepsy not controlled by drugs, serious visual disturbances...);
inability to follow verbal instructions.
Trial design
Design model
Single group
Treatments tested in this trial
Instrumented Stair Climb Test
Other interventionInstrumented test of climbing and descending stairs for the evaluation of kinematic and electromyographic variables. The test consists of repeating the ascent and descent of a flight of 10-12 steps;
Walk Test
Other interventionAssessment of climbing and walking skills through test series: Borg scale: An evaluation scale for measuring effort perception. The evaluation scale consists of answering some questions at the end of the exercise described above; 10-metre walk test (10MWT): Test to assess walking speed in metres per second over a short distance. Can be used to determine functional mobility, gait and vestibular function. The test consists of walking at a steady speed and safely for 10 metres; 30 second sit to stand test: test for the evaluation of strength and endurance of the legs in the elderly. The test consists in performing the movement of standing up and sitting down from a chair for 30 consecutive seconds; Timed Up \& Go test (TUG): test to assess the risk of falling and balance. During the test, patients wear normal footwear and may use a walking aid if necessary. The patient starts in a sitting position, gets up on the therapist's command, walks in a straight line for a distance of 3 m
Repaeted Instrumented Stair Climb Test
Other interventionInstrumented test of climbing and descending stairs for the evaluation of kinematic and electromyographic variables. The test consists of repeating the ascent and descent of a flight of 10-12 steps. In this case, the ascent and descent of the stairs must be repeated two times. Between the two trial the IMU units must be repositioned.
Treatment groups
64 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: healthy childrenOther 2 interventions
Group B: Healthy adultsOther 2 interventions
Group C: Healthy elderlyOther 2 interventions
Group D: CP subjectsOther 2 interventions
Group E: Leg amputee subjectsOther 2 interventions
Group F: Arthroplasty SubjectsOther 2 interventions
Group G: Parkinson SubjectsOther 2 interventions
Group H: Stroke SubjectsOther 2 interventions
Trial outcomes
Primary outcomes
1
Absolue error automatic test time
Absolute errors were calculated for the duration time of the stair ascent and descent and for each variable by taking the absolute value after subtracting the values obtained using IMU methods from the value measured using the tradional chronometer method
Time frame
Through study completion, an average of 1 year2
Intra - inter operator variability
To ensure consistency between the data obtained by the IMU method and the data obtained by the traditional chronometric method, the investigators first calculated the normality of the data. The two-way mixed effects model, absolute agreement, and average measurements were used to calculate the ICCs between the duration time of both systems in case of normality. Instead, the Sperman test was used by the investigator if the data had a non-normal distribution
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
correlations with Ten meters Walk Test (10mWT)
The investigators determine if there are any correlations between the instrumental data gathered from a test performed using the IMU method and the clinical test of the Ten meters walking test (10mWT). In the 10mWT the total time taken to ambulate 6 meters (m) is recorded to the nearest hundredth of a second. 6 m is then divided by the total time (in seconds) taken to ambulate and recorded in m/s.
Time frame
Through study completion, an average of 1 year2
correlations with 30 seconds chair to stand test
The investigators determine if there are any correlations between the instrumental data gathered from a test performed using the IMU method and the clinical test of the 30 seconds chair to stand test. The test score is the total number of lifts completed in 30 seconds. During the test, the participant can stop and rest if he is tired without stopping time. If a person fails to perform any high the score for the test is zero
Time frame
Through study completion, an average of 1 year3
correlations with Timed Up and Go (TUG)
The investigators determine if there are any correlations between the instrumental data gathered from a test performed using the IMU method and the clinical test Timed Up and Go test (TuG). The score in the text corresponds to the time taken by the participants to get up, walk to a distance of 3 m, turn around and return to their seats. Regular walking aids are permitted and recorded if necessary.
Time frame
Through study completion, an average of 1 year4
correlations with Borg Scale
The investigators determine if there are any correlations between the instrumental data gathered from a test performed using the IMU method and the clinical Borg Scale. This is a scale to assess the intensity of exercise without having to rely on physiological parameters. The original Borg version is a scale of 6-20.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS Eugenio Medea
Lead sponsor
Politecnico di Milano
Collaborator
ASP Istituti Milanesi Martinitt e Stelline e Pio Albergo Trivulzio
Collaborator
Istituti Clinici Scientifici Maugeri SpA
Collaborator
Source ClinicalTrials.gov