NCT07292545

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

July 10, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

July 14, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 18, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

July 10, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

amyotrophic latearl sclerosisproprioceptionvideo based exercise

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    1st week and 7th week

Secondary Outcomes (2)

  • Trunk control

    1st week and 7th week

  • QoL

    1st week and 7th week

Study Arms (1)

video based exercise

EXPERIMENTAL
Other: video based exercise

Interventions

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

video based exercise

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Mersin, TARSUS, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Evrim GOZ, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 10, 2025

First Posted

December 18, 2025

Study Start

July 14, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 18, 2025

Record last verified: 2025-10

Locations