Amyotrophic Lateral SclerosisALSNCT07292545
Video-Based Proprioceptive Exercise Program in ALS
A study testing video based exercise in people with Amyotrophic Lateral Sclerosis, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
In the project, it was aimed to evaluate the proprioceptive system in the disease, which is still mysterious and therefore has no curative treatment under current conditions, and to examine the effects of the video-based proprioceptive home exercise programme on trunk and limb control and daily life activity as well… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- video based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ALS patients aged 18-70
- Those with a definite ALS diagnosis according to the Gold Coast criteria
- Those who can sit independently
- Those who have no cognitive problems
- Those who agree to participate in the study will be included in the study.
Who cannot join
- ALS patients with neurological, orthopedic or visual dysfunction mimicking ALS,
- Those who cannot complete active joint movements in the upper and lower extremities,
- ALS patients who do not agree to participate in the study will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tarsus University
Mersin, TARSUS
EVRİM GÖZ, ASSOC PROF, +905368991930, evrimgoz@tarsus.edu.tr
evrim Göz, Assoc Prof, +905368991930
About this study
Official title: Examining the Effectiveness of Video-Based Proprioceptive Home Exercise Program in Amyotrophic Lateral Sclerosis Patients
In the project, it was aimed to evaluate the proprioceptive system in the disease, which is still mysterious and therefore has no curative treatment under current conditions, and to examine the effects of the video-based proprioceptive home exercise programme on trunk and limb control and daily life activity as well as trunk and limb control. The study was planned to include 20 patients with a definite diagnosis of ALS. Proprioceptive sensory examination will be performed again in these patients, who are currently being followed up with ALS diagnosis and whose physical examination including neurological examination has been performed in detail, and the "Revised Amyotrophic Lateral Sclerosis Functional Rating Scale" (R-ALSFRS) will be applied to the patients. Subsequently, the patients will be followed up by applying a video-based proprioceptive home exercise programme 3 days a week for 8 weeks. At the end of the 8th week, a detailed neurological examination including proprioceptive sensation will be performed and the R-ALSFRS scale will be applied. In addition, ALS quality of life scale will be applied to the patients before and after the home programme. The data obtained after the treatment programme will be analysed and interpreted.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease characterised mainly by degeneration of upper and lower motor neurons. In recent years, the disease paradigm has changed and ALS has been increasingly recognised as a multi-systemic disease in which the sensory system is also affected rather than a disease limited to motor neurons. The proprioceptive system is the primary sensory system that is vital in managing motor control. Recent studies suggest that sensory impairment may occur early in ALS and that there is degeneration in proprioceptive sensory neurons. However, in the current literature, there is no study that clinically evaluates proprioception in ALS patients or provides proprioceptive training to patients. In addition, progressive muscle degeneration is frequently seen in the trunk and distal muscles in ALS, which negatively affects trunk control and leads to a decrease in the independence of patients in daily life activities and thus quality of life. In the project, it was aimed to evaluate the proprioceptive system in the disease, which is still mysterious and therefore has no curative treatment under current conditions, and to examine the effects of the video-based proprioceptive home exercise programme on trunk and limb control and daily life activity as well as trunk and limb control. The study was planned to include 20 patients with a definite diagnosis of ALS. Proprioceptive sensory examination will be performed again in these patients, who are currently being followed up with ALS diagnosis and whose physical examination including neurological examination has been performed in detail, and the "Revised Amyotrophic Lateral Sclerosis Functional Rating Scale" (R-ALSFRS) will be applied to the patients. Subsequently, the patients will be followed up by applying a video-based proprioceptive home exercise programme 3 days a week for 8 weeks. At the end of the 8th week, a detailed neurological examination including proprioceptive sensation will be performed and the R-ALSFRS scale will be applied. In addition, ALS quality of life scale will be applied to the patients before and after the home programme. The data obtained after the treatment programme will be analysed and interpreted. In the literature, the number of publications on proprioception in ALS patients is very limited. The successful completion of this project will shed light on the pathogenesis of the disease and will contribute to the planning of new researches at national and international level.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- video based exercise
- Keywords
- amyotrophic latearl sclerosis, proprioception, video based exercise
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video based exerciseOther
Description: The proprioceptive home exercises that will be presented to patients who meet the inclusion criteria and whose preliminary evaluation has been completed will be taught by a physiotherapist in a clinical setting, and all questions about the exercises will be answered. The proprioceptive home exercises program includes 60 and 120 degrees of shoulder flexion with eyes open and closed, respectively, while lying on the back, shoulder abduction, 65 and full normal joint movement limit elbow flexion with eyes open and closed, respectively, while lying on the back, hip and knee flexion with eyes open and closed, respectively, 90 degrees of knee flexion with eyes open and closed, respectively, while sitting, 45 and 90 degrees of knee flexion with eyes open and closed, respectively, forward and side reaching movements in the sitting position, and sitting position, eyes open and then eyes closed, for 1 minute. All patients will be asked to perform these exercises. For patients who c
| Study group | Role | What they receive |
|---|---|---|
| video based exercise | Experimental | Not described Receives: Other: video based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength assesment
The muscle strength assessment of ALS patients will be performed with Hoggan microFET2 (Hoggan Scientific, LLC, Salt Lake City UT, USA). It is a hand-held dynamometer. Patients are asked to perform the movement at maximum force without using a compensation mechanism, and the researcher applies resistance in the opposite direction of the movement without creating any movement in the joint, in a way that creates isometric contraction. The strength of the hip flexor, quadriceps femoris, shoulder flexor, elbow extensor, elbow flexor, trunk extensor and flexor muscles will be evaluated. 3 measurements will be taken for each muscle group and the average will be taken. There will be a 30-second rest period between measurements. The evaluations will be made by the physiotherapist.
Measured: 1st week and 7th week
proprioception assessment
For proprioception assessment, upper extremity position sense, lower extremity position sense and trunk position sense will be assessed. Assessment of position sense J-Tech™ dual Inclinometer will be used to assess position sense. Participants will be asked to stand in a static position. For upper extremity position sense, measurements will be made in 3 separate tests with the shoulder at 60 degrees of flexion, 60 degrees of abduction and the elbow at 65 degrees of flexion. First, individuals will be asked to learn the target angle with their eyes open, then they will be asked to find the target angle with their eyes closed. Both extremities will be measured with an inclinometer and recorded. Each measurement will be performed 3 times and the average of the 3 measurements will be used for the final analysis. The knee joint will be evaluated for lower extremity position sense measurement. The knees of the errors will be flexed to 60 degr
Measured: 1st week and 7th week
functional status
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (R-ALSFRS) This scale, which determines the functional status of ALS patients, is the most frequently used scale in daily practice and in studies on the subject and consists of 12 headings, each scored between 0-4. While a functionally normal patient receives 48 points, the scores decrease downward due to functional deterioration. The Turkish validity and reliability study of the scale was conducted by Koç et al.
Measured: 1st week and 7th week
Secondary outcomes (2)
Trunk control
To evaluate trunk control, the Trunk Impairment Scale and the postural sway assessment in the sitting position will be performed. Trunk Impairment Scale: The Trunk Impairment Scale, developed by Verheyden et al., evaluates static and dynamic sitting balance and trunk coordination in the sitting position. The total score that can be obtained varies between 0 for minimum performance and 23 for good performance. Postural sway assessment: Postural sway assessment in the sitting position will be evaluated with GyKo (Microgate, Bolzano, Italy), which is used in movement analysis. The device performs acceleration measurement and transfers simplified data with scientifically validated algorithms directly to the computer via Microgate software, allowing real-time measurement. The GyKo sensor will be fixed to the person's torso with the help of attachment straps at the T1-T2 thoracic vertebrae level. After the patients sit on a stool suitable for their height, they are
Measured: 1st week and 7th week
QoL
The Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) will be used to assess quality of life in ALS patients. It is a 40-question scale developed to assess quality of life in patients with ALS. The scale consists of 5 sub-dimensions: mobility, activities of daily living (ADL), eating and drinking, communication, and emotional functioning. The lowest score that can be obtained from the scale is 0, the highest score is 100, with a high score indicating poor quality of life .
Measured: 1st week and 7th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start14 Jul 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Evrim GÖZ, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292545
- Sponsor's protocol ID
- TarsusUftr
- Acronym
- ALS
- Status last verified
- Oct 2025
- First submitted
- 10 Jul 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of Video-Based Proprioceptive Home Exercise Program in Amyotrophic Lateral Sclerosis Patients
- ClinicalTrials.gov ID
- NCT07292545
- Acronym / sponsor ID
- ALS / TarsusUftr
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- amyotrophic latearl sclerosis, proprioception, video based exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (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.
In the project, it was aimed to evaluate the proprioceptive system in the disease, which is still mysterious and therefore has no curative treatment under current conditions, and to examine the effects of the video-based proprioceptive home exercise programme on trunk and limb control and daily life activity as well as trunk and limb control. The study was planned to include 20 patients with a definite diagnosis of ALS. Proprioceptive sensory examination will be performed again in these patients, who are currently being followed up with ALS diagnosis and whose physical examination including neurological examination has been performed in detail, and the "Revised Amyotrophic Lateral Sclerosis Functional Rating Scale" (R-ALSFRS) will be applied to the patients. Subsequently, the patients will be followed up by applying a video-based proprioceptive home exercise programme 3 days a week for 8 weeks. At the end of the 8th week, a detailed neurological examination including proprioceptive sensation will be performed and the R-ALSFRS scale will be applied. In addition, ALS quality of life scale will be applied to the patients before and after the home programme. The data obtained after the treatment programme will be analysed and interpreted.
Detailed description
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease characterised mainly by degeneration of upper and lower motor neurons. In recent years, the disease paradigm has changed and ALS has been increasingly recognised as a multi-systemic disease in which the sensory system is also affected rather than a disease limited to motor neurons. The proprioceptive system is the primary sensory system that is vital in managing motor control. Recent studies suggest that sensory impairment may occur early in ALS and that there is degeneration in proprioceptive sensory neurons. However, in the current literature, there is no study that clinically evaluates proprioception in ALS patients or provides proprioceptive training to patients. In addition, progressive muscle degeneration is frequently seen in the trunk and distal muscles in ALS, which negatively affects trunk control and leads to a decrease in the independence of patients in daily life activities and thus quality of life. In the project, it was aimed to evaluate the proprioceptive system in the disease, which is still mysterious and therefore has no curative treatment under current conditions, and to examine the effects of the video-based proprioceptive home exercise programme on trunk and limb control and daily life activity as well as trunk and limb control. The study was planned to include 20 patients with a definite diagnosis of ALS. Proprioceptive sensory examination will be performed again in these patients, who are currently being followed up with ALS diagnosis and whose physical examination including neurological examination has been performed in detail, and the "Revised Amyotrophic Lateral Sclerosis Functional Rating Scale" (R-ALSFRS) will be applied to the patients. Subsequently, the patients will be followed up by applying a video-based proprioceptive home exercise programme 3 days a week for 8 weeks. At the end of the 8th week, a detailed neurological examination including proprioceptive sensation will be performed and the R-ALSFRS scale will be applied. In addition, ALS quality of life scale will be applied to the patients before and after the home programme. The data obtained after the treatment programme will be analysed and interpreted. In the literature, the number of publications on proprioception in ALS patients is very limited. The successful completion of this project will shed light on the pathogenesis of the disease and will contribute to the planning of new researches at national and international level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| video based exercise | Experimental | Other: video based exercise |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ALS patients aged 18-70
- Those with a definite ALS diagnosis according to the Gold Coast criteria
- Those who can sit independently
- Those who have no cognitive problems
- Those who agree to participate in the study will be included in the study.
Key exclusion criteria (3 listed)
- ALS patients with neurological, orthopedic or visual dysfunction mimicking ALS,
- Those who cannot complete active joint movements in the upper and lower extremities,
- ALS patients who do not agree to participate in the study will not be included 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 |
|---|---|---|
| video based exerciseDescription: The proprioceptive home exercises that will be presented to patients who meet the inclusion criteria and whose preliminary evaluation has been completed will be taught by a physiotherapist in a clinical setting, and all questions about the exercises will be answered. The proprioceptive home exercises program includes 60 and 120 degrees of shoulder flexion with eyes open and closed, respectively, while lying on the back, shoulder abduction, 65 and full normal joint movement limit elbow flexion with eyes open and closed, respectively, while lying on the back, hip and knee flexion with eyes open and closed, respectively, 90 degrees of knee flexion with eyes open and closed, respectively, while sitting, 45 and 90 degrees of knee flexion with eyes open and closed, respectively, forward and side reaching movements in the sitting position, and sitting position, eyes open and then eyes closed, for 1 minute. All patients will be asked to perform these exercises. For patients who c | Other | video based exercise |
Primary outcome
muscle strength assesment
Time frame: 1st week and 7th week
The muscle strength assessment of ALS patients will be performed with Hoggan microFET2 (Hoggan Scientific, LLC, Salt Lake City UT, USA). It is a hand-held dynamometer. Patients are asked to perform the movement at maximum force without using a compensation mechanism, and the researcher applies resistance in the opposite direction of the movement without creating any movement in the joint, in a way that creates isometric contraction. The strength of the hip flexor, quadriceps femoris, shoulder flexor, elbow extensor, elbow flexor, trunk extensor and flexor muscles will be evaluated. 3 measurements will be taken for each muscle group and the average will be taken. There will be a 30-second rest period between measurements. The evaluations will be made by the physiotherapist.
proprioception assessment
Time frame: 1st week and 7th week
For proprioception assessment, upper extremity position sense, lower extremity position sense and trunk position sense will be assessed. Assessment of position sense J-Tech™ dual Inclinometer will be used to assess position sense. Participants will be asked to stand in a static position. For upper extremity position sense, measurements will be made in 3 separate tests with the shoulder at 60 degrees of flexion, 60 degrees of abduction and the elbow at 65 degrees of flexion. First, individuals will be asked to learn the target angle with their eyes open, then they will be asked to find the target angle with their eyes closed. Both extremities will be measured with an inclinometer and recorded. Each measurement will be performed 3 times and the average of the 3 measurements will be used for the final analysis. The knee joint will be evaluated for lower extremity position sense measurement. The knees of the errors will be flexed to 60 degr
functional status
Time frame: 1st week and 7th week
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (R-ALSFRS) This scale, which determines the functional status of ALS patients, is the most frequently used scale in daily practice and in studies on the subject and consists of 12 headings, each scored between 0-4. While a functionally normal patient receives 48 points, the scores decrease downward due to functional deterioration. The Turkish validity and reliability study of the scale was conducted by Koç et al.
2 secondary outcomes
Trunk control
Time frame: 1st week and 7th week
QoL
Time frame: 1st week and 7th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video based exercise in people with Amyotrophic Lateral Sclerosis, run by Tarsus 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evrim GOZ, Assoc. Prof. (03246000033, fzt_evrim@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength assesment (time frame: 1st week and 7th week). The study lists 3 primary outcomes in all. 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 18 Dec 2025.