Video-Based Proprioceptive Exercise Program in ALS (ALS)

December 15, 2025 updated by: Evrim GÖZ, Tarsus University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • TARSUS
      • Mersin, TARSUS, Turkey (Türkiye)
        • Recruiting
        • Tarsus University
        • Contact:
        • Contact:
          • evrim Göz, Assoc Prof
          • Phone Number: +905368991930

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: video based exercise
Other: video based exercise
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1st week and 7th week
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
1st week and 7th week
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.
1st week and 7th week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trunk control
Time Frame: 1st week and 7th week
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
1st week and 7th week
QoL
Time Frame: 1st week and 7th week
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 .
1st week and 7th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tarsus University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TarsusUftr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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