DriveNCT06297798
Effects of Telerehabilitation-Based Interventions on the Musculoskeletal System in Drivers
A study testing Telerehabilitation in people with Drive and Musculoskeletal Diseases, run by Sakarya Applied Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study is designed to examine the effect of telerehabilitation application on the musculoskeletal system of drivers.The study will include 40 voluntary participants who work as drivers on inter-district routes in Sakarya. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drive, Musculoskeletal Diseases, Postural; Defect
- What is being tested?
- Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2024to 10 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals working as drivers in intercity minibuses in Sakarya.
- Those who have been working as drivers for at least one year.
- Age between 30 and 65.
- Male gender.
- Those who can use a smartphone.
- Those who can use at least one of the following applications: WhatsApp, Zoom, or Teams.
Who cannot join
- Orthopedic surgeries undergone within the past year.
- Inability to obtain consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University of Applied Sciences
Sakarya, 54000
Nurgul SEN, Master's degree, 05344527440, pakizesen@subu.edu.tr
Ceyhun TURKMEN, Assoc. Prof.
About this study
Official title: Effects of Telerehabilitation-Based Interventions on the Musculoskeletal System in Drivers: A Crossover Longitudinal Study
This study is designed to examine the effect of telerehabilitation application on the musculoskeletal system of drivers.The study will include 40 voluntary participants who work as drivers on inter-district routes in Sakarya. The participants' sociodemographic information, musculoskeletal problems, and postures will be assessed. Participants will be divided into two groups: one group will receive tele-rehabilitation with posture and stabilization exercises, while the other group will serve as the control group. The exercises will be implemented for 10 weeks, followed by an 8-week tapering period, after which the groups will be crossed over. A re-evaluation will be conducted after 10 weeks, with follow-up assessments scheduled for 3 months later.
Read the detailed description
The aim of the research is to investigate the effectiveness of telerehabilitation-based interventions in the management and improvement of common musculoskeletal disorders prevalent among drivers. This study will longitudinally examine the potential effects of developing and implementing customized posture and stabilization exercise programs for reducing posture and musculoskeletal disorders in drivers. The goal is to provide evidence of the effectiveness of telerehabilitation applications on the musculoskeletal health of drivers.
The study plans to involve 40 male volunteers aged 30-65 engaged in inter-district driving in Sakarya. Inclusion criteria for the study include working as an inter-district driver, driving a vehicle for at least 6 hours per day for a minimum of one year, and the ability to use at least one of the WhatsApp, Zoom, or Teams applications. Exclusion criteria include undergoing orthopedic surgery in the past year and a lack of consent to participate in the study. Within the scope of the study, sociodemographic information will be collected from all participants, their postures will be assessed using the "posture screen" application, and musculoskeletal problems will be evaluated using the "Cornell Musculoskeletal Disorders Questionnaire."
At the end of the assessment, participants will be divided into two groups using the layered randomization method. The intervention group will receive posture and stabilization exercises through telerehabilitation via WhatsApp, Zoom, or Teams applications for 45 minutes per day, five days a week, for 10 weeks. General advice will be given to both groups, but no exercise program will be provided to the control group. After 10 weeks, the same assessments will be conducted for both the control and intervention groups. Subsequently, an 8-week tapering period will be expected, followed by the crossover of the groups. Those initially in the intervention group will form the control group, and vice versa.
After 10 weeks of training, the same assessments will be conducted again, and following this assessment, a final evaluation will be conducted 3 months later to complete the follow-up.
- Conditions
- Drive, Musculoskeletal Diseases, Postural; Defect
- Being tested
- Telerehabilitation
- Keywords
- drivers, musculoskeletal system disease, posture, longitudinal study
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
The telerehabilitation program will be implemented using Whatsapp and Zoom applications for 40 minutes, 5 days a week. Posture and stabilization exercises will be performed, and the exercises will be performed for 10 weeks.
Posture and Stabilization Exercise Program:
- Stretching of neck flexor, extensor, and lateral flexor muscles (30 seconds each)
- Pectoral muscle stretching (30 seconds, 3 repetitions)
- Isometric neck exercises (10 seconds, 10 repetitions)
- Rhomboid strengthening exercise (bringing shoulder blades closer together against resistance using a TheraBand) (10 seconds, 10 repetitions)
- Stretching of hamstring, lumbar lordosis and gastrocnemius muscles (sitting and standing) (30 seconds, 3 repetitions)
- Pelvic posterior tilt exercise (10 seconds, 10 repetitions)
- Bridge exercise (20 seconds, 10 repetitions)
- Single-leg bridge exercise (Right-Left) (10 seconds, 10 repetitions)
- Plank (starting with 60 seconds, increasing by 10 seconds each week)
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Experimental | In the telerehabilitation group, posture and stabilization exercises will be performed using Whatsapp and Zoom applications for 40 minutes, 5 days a week. Exercises will be applied for 10 weeks.
Posture and Stabilization Exercise Program:
1. Stretching of neck flexor, extensor, and lateral flexor muscles (30 seconds each)
2. Pectoral muscle stretching (30 seconds, 3 repetitions)
3. Isometric neck exercises (10 seconds, 10 repetitions)
4. Rhomboid strengthening exercise (bringing shoulder blades closer together against resistance using a TheraBand) (10 seconds, 10 repetitions)
5. Stretching of hamstring, lumbar lordosis and gastrocnemius muscles (sitting and standing) (30 seconds, 3 repetitions)
6. Pelvic posterior tilt exercise (10 seconds, 10 repetitions)
7. Bridge exercise (20 seconds, 10 repetitions)
8. Single-leg bridge exercise (Right-Left) (10 seconds, 10 repetitions)
9. Plank (starting with 60 seconds, increasing by 10 seconds each week) Receives: Other: Telerehabilitation |
| Control Group | No intervention | The control group will not be given any exercise program; instead, general posture recommendations will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MUSCLE SKELETAL SYSTEM ASSESSMENT
The Cornell Musculoskeletal System Questionnaire will be used for musculoskeletal system evaluation. While conducting the survey, the illnesses experienced by the employees in the last week are taken as basis. In this survey, neck, shoulder (right-left), back, upper arm (right-left), waist, forearm (right-left), wrist (right-left), hip, upper leg (right-left), knee. Questions are asked for 20 body parts such as (right-left), lower leg (right-left) and foot (right-left) and the risk score is calculated as a result of the answers received. While calculating the relevant score, risk scores are calculated separately for each body region by multiplying scores such as the number of times the employee has experienced the discomfort in the current area, the severity of the discomfort felt and the obstacle in working. The final total score is calculated. A high score indicates high discomfort.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Posture Measures
Posture evaluation will be made using the "PostureScreen Mobile" application. This application is a reliable and valid mobile tool designed specifically to assess static posture and, in particular, forward head tilt. All participants will be allowed to wear thin, tight clothing provided that reference anatomical landmarks are clearly visible. All evaluations will be repeated in the same place and under the same conditions. The photo will always be taken from a distance of 10 feet (approximately 3.5 meters) and from a height of 3.5 feet (approximately 1.5 meters).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start14 Mar 2024 (estimated)
- Primary completion21 Mar 2024 (estimated)
- Study completion10 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DriveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya Applied Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pakize Nurgul Sen, Sakarya Applied Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297798
- Sponsor's protocol ID
- SakaryaAppliedSciencesUPNS
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Telerehabilitation-Based Interventions on the Musculoskeletal System in Drivers: A Crossover Longitudinal Study
- ClinicalTrials.gov ID
- NCT06297798
- Acronym / sponsor ID
- SakaryaAppliedSciencesUPNS
- Conditions
- Drive, Musculoskeletal Diseases, Postural; Defect
- Keywords
- drivers, musculoskeletal system disease, posture, longitudinal study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sakarya Applied Sciences UniversityUniversity, hospital or other
- Study start
- 14 Mar 2024 (estimated)
- Primary completion
- 21 Mar 2024 (estimated)
- Study completion
- 10 May 2024 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to examine the effect of telerehabilitation application on the musculoskeletal system of drivers.The study will include 40 voluntary participants who work as drivers on inter-district routes in Sakarya. The participants' sociodemographic information, musculoskeletal problems, and postures will be assessed. Participants will be divided into two groups: one group will receive tele-rehabilitation with posture and stabilization exercises, while the other group will serve as the control group. The exercises will be implemented for 10 weeks, followed by an 8-week tapering period, after which the groups will be crossed over. A re-evaluation will be conducted after 10 weeks, with follow-up assessments scheduled for 3 months later.
Detailed description
The aim of the research is to investigate the effectiveness of telerehabilitation-based interventions in the management and improvement of common musculoskeletal disorders prevalent among drivers. This study will longitudinally examine the potential effects of developing and implementing customized posture and stabilization exercise programs for reducing posture and musculoskeletal disorders in drivers. The goal is to provide evidence of the effectiveness of telerehabilitation applications on the musculoskeletal health of drivers.
The study plans to involve 40 male volunteers aged 30-65 engaged in inter-district driving in Sakarya. Inclusion criteria for the study include working as an inter-district driver, driving a vehicle for at least 6 hours per day for a minimum of one year, and the ability to use at least one of the WhatsApp, Zoom, or Teams applications. Exclusion criteria include undergoing orthopedic surgery in the past year and a lack of consent to participate in the study. Within the scope of the study, sociodemographic information will be collected from all participants, their postures will be assessed using the "posture screen" application, and musculoskeletal problems will be evaluated using the "Cornell Musculoskeletal Disorders Questionnaire."
At the end of the assessment, participants will be divided into two groups using the layered randomization method. The intervention group will receive posture and stabilization exercises through telerehabilitation via WhatsApp, Zoom, or Teams applications for 45 minutes per day, five days a week, for 10 weeks. General advice will be given to both groups, but no exercise program will be provided to the control group. After 10 weeks, the same assessments will be conducted for both the control and intervention groups. Subsequently, an 8-week tapering period will be expected, followed by the crossover of the groups. Those initially in the intervention group will form the control group, and vice versa.
After 10 weeks of training, the same assessments will be conducted again, and following this assessment, a final evaluation will be conducted 3 months later to complete the follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group | Experimental | Other: TelerehabilitationIn the telerehabilitation group, posture and stabilization exercises will be performed using Whatsapp and Zoom applications for 40 minutes, 5 days a week. Exercises will be applied for 10 weeks. Posture and Stabilization Exercise Program: 1. Stretching of neck flexor, extensor, and lateral flexor muscles (30 seconds each) 2. Pectoral muscle stretching (30 seconds, 3 repetitions) 3. Isometric neck exercises (10 seconds, 10 repetitions) 4. Rhomboid strengthening exercise (bringing shoulder blades closer together against resistance using a TheraBand) (10 seconds, 10 repetitions) 5. Stretching of hamstring, lumbar lordosis and gastrocnemius muscles (sitting and standing) (30 seconds, 3 repetitions) 6. Pelvic posterior tilt exercise (10 seconds, 10 repetitions) 7. Bridge exercise (20 seconds, 10 repetitions) 8. Single-leg bridge exercise (Right-Left) (10 seconds, 10 repetitions) 9. Plank (starting with 60 seconds, increasing by 10 seconds each week) |
| Control Group | No intervention | –The control group will not be given any exercise program; instead, general posture recommendations will be given. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals working as drivers in intercity minibuses in Sakarya.
- Those who have been working as drivers for at least one year.
- Age between 30 and 65.
- Male gender.
- Those who can use a smartphone.
Key exclusion criteria (2 listed)
- Orthopedic surgeries undergone within the past year.
- Inability to obtain consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationThe telerehabilitation program will be implemented using Whatsapp and Zoom applications for 40 minutes, 5 days a week. Posture and stabilization exercises will be performed, and the exercises will be performed for 10 weeks. Posture and Stabilization Exercise Program: 1. Stretching of neck flexor, extensor, and lateral flexor muscles (30 seconds each) 2. Pectoral muscle stretching (30 seconds, 3 repetitions) 3. Isometric neck exercises (10 seconds, 10 repetitions) 4. Rhomboid strengthening exercise (bringing shoulder blades closer together against resistance using a TheraBand) (10 seconds, 10 repetitions) 5. Stretching of hamstring, lumbar lordosis and gastrocnemius muscles (sitting and standing) (30 seconds, 3 repetitions) 6. Pelvic posterior tilt exercise (10 seconds, 10 repetitions) 7. Bridge exercise (20 seconds, 10 repetitions) 8. Single-leg bridge exercise (Right-Left) (10 seconds, 10 repetitions) 9. Plank (starting with 60 seconds, increasing by 10 seconds each week) | Other | Telerehabilitation Group |
Primary outcome
MUSCLE SKELETAL SYSTEM ASSESSMENT
Time frame: Through study completion, an average of 1 year
The Cornell Musculoskeletal System Questionnaire will be used for musculoskeletal system evaluation. While conducting the survey, the illnesses experienced by the employees in the last week are taken as basis. In this survey, neck, shoulder (right-left), back, upper arm (right-left), waist, forearm (right-left), wrist (right-left), hip, upper leg (right-left), knee. Questions are asked for 20 body parts such as (right-left), lower leg (right-left) and foot (right-left) and the risk score is calculated as a result of the answers received. While calculating the relevant score, risk scores are calculated separately for each body region by multiplying scores such as the number of times the employee has experienced the discomfort in the current area, the severity of the discomfort felt and the obstacle in working. The final total score is calculated. A high score indicates high discomfort.
1 secondary outcome
Posture Measures
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Drive and Musculoskeletal Diseases, run by Sakarya Applied Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MUSCLE SKELETAL SYSTEM ASSESSMENT (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.