NCT06554483

Brief Summary

Neuroscience based proprioceptive exercise trainig using laser pointer (nbpet) is a new aproach exercise training method. In this study, This study aimed to investigate the effects of nbpet using laser pointer on different fonctional parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 3, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

July 25, 2024

Last Update Submit

May 27, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • pain meausere

    Short-form McGill Pain Questionnaire (SF-MPQ) will used to examine pain level of participants. The main component of the SF-MPQ consists of 15 descriptive adjectives for the pain sensation (11 sensory and 4 affective), which are self-rated by the patient according to their intensity level on a point rating scale (0 = none,1 = mild, 2 = moderate, 3 = severe). Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The total score is the sum of the intensity values.

    6 weeks

  • position error

    Joint Position Error measurement will used to asses knee proprioception of elderly. It is a test performed with a wall-mounted board consisting of circles drawn at a distance of 1 cm from the patient and a laser placed on the patient's knee with appropriate belts. After the laser is placed on the patient's knee, the patient stands and tries to hold the laser light at the starting point with eyes open on the board placed 90 cm away. The patient is first asked to perform 10 repetitions of knee flexion and extension and then to return the laser to the starting position with eyes closed. In the final stage, the patient's horizontal, vertical and global distance from the laser light starting point is recorded in cm

    6 weeks

Secondary Outcomes (4)

  • Range of motion

    6 weeks

  • Qualitiy of life

    6 weeks

  • Kinesiophobia

    6 weeks

  • Time up and Go test

    6 weeks

Study Arms (2)

neuroscience based proprioceptive exercise training group

EXPERIMENTAL

Neuroscience based proprioceptive training using laser pointer A pre-created wallpaper indicating various directions is fixed on the wall 90 cm away from the patient (at the level of the patient's knee when the patient is standing upright). Then, the laser pointer (producted by NMC training system) will fixed to the patient's knee with the help of a velcro so as not to interfere with the patient's knee movement. At the beginning of the exercise, the patient is asked to move the light on the laser pointer to the midpoint of the wallpaper. The patient is then asked to follow the instructions on the wallpaper by moving the knee in flexion-extension, medio-lateral directions. These instructions are continued throughout the exercise in different directions. Meanwhile, the patient is asked to perform mild cognitive tasks such as counting numbers, names of people starting with any letter, city names or animal names. The training continued for approximately 20 minutes.

Other: Exercise

Proprioceptive exercise group

ACTIVE COMPARATOR

A proprioceptive training regimen will established with Swiss balls. The proprioceptive activities are advanced on a weekly basis in order to test the patient's balance in response. Patients have training in three stages: beginning, intermediate, and advanced. Each exercise is performed as 3x10 repetitions. Between sets, 2-3 minutes rest breaks is given. The beginning phase is applied in the 1st and 2nd weeks, the intemediate phase in the 3rd and 4th weeks, and the advanced phase in the 5th and 6th weeks.

Other: Exercise

Interventions

supportive reliable exercise programs

Also known as: Proprioceptive exercise
Proprioceptive exercise groupneuroscience based proprioceptive exercise training group

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having a history of knee pain for 6 months or longer
  • having unilateral knee pain, being 60 years of age or older, and completing the assessments.

You may not qualify if:

  • being under 60 years of age, having bilateral knee pain
  • being diagnosed with a disease that may cause knee pain (osteatritis, meniscus rupture, ACL rupture...)
  • having knee pain for less than 6 months
  • have visual and hearing impairments that affect exercise, having knee extension limitations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aziz DENGIZ

Muş, 49100, Turkey (Türkiye)

Location

Related Publications (15)

  • Takahashi A, Kitamura K, Watanabe Y, Kobayashi R, Saito T, Takachi R, Kabasawa K, Oshiki R, Tsugane S, Iki M, Sasaki A, Yamazaki O, Nakamura K. Epidemiological profiles of chronic low back and knee pain in middle-aged and elderly Japanese from the Murakami cohort. J Pain Res. 2018 Dec 12;11:3161-3169. doi: 10.2147/JPR.S184746. eCollection 2018.

    PMID: 30588068BACKGROUND
  • Mitchell HL, Hurley MV. Management of chronic knee pain: a survey of patient preferences and treatment received. BMC Musculoskelet Disord. 2008 Sep 18;9:123. doi: 10.1186/1471-2474-9-123.

    PMID: 18801169BACKGROUND
  • Bjordal JM, Ljunggren AE, Klovning A, Slordal L. Non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials. BMJ. 2004 Dec 4;329(7478):1317. doi: 10.1136/bmj.38273.626655.63. Epub 2004 Nov 23.

    PMID: 15561731BACKGROUND
  • Gutthann SP, Garcia Rodriguez LA, Raiford DS. Individual nonsteroidal antiinflammatory drugs and other risk factors for upper gastrointestinal bleeding and perforation. Epidemiology. 1997 Jan;8(1):18-24. doi: 10.1097/00001648-199701000-00003.

    PMID: 9116088BACKGROUND
  • Juni P, Reichenbach S, Egger M. COX 2 inhibitors, traditional NSAIDs, and the heart. BMJ. 2005 Jun 11;330(7504):1342-3. doi: 10.1136/bmj.330.7504.1342. No abstract available.

    PMID: 15947376BACKGROUND
  • Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.

    PMID: 22357571BACKGROUND
  • Jiang L, Zhang L, Huang W, Zeng Q, Huang G. The effect of proprioception training on knee kinematics after anterior cruciate ligament reconstruction: A randomized control trial. J Back Musculoskelet Rehabil. 2022;35(5):1085-1095. doi: 10.3233/BMR-210201.

    PMID: 35213344BACKGROUND
  • Hajouj E, Hadian MR, Mir SM, Talebian S, Ghazi S. Effects of Innovative Aquatic Proprioceptive Training on Knee Proprioception in Athletes with Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Arch Bone Jt Surg. 2021 Sep;9(5):519-526. doi: 10.22038/abjs.2020.50106.2485.

    PMID: 34692934BACKGROUND
  • Genevsky A, Garrett CT, Alexander PP, Vinogradov S. Cognitive training in schizophrenia: a neuroscience-based approach. Dialogues Clin Neurosci. 2010;12(3):416-21. doi: 10.31887/DCNS.2010.12.3/agenevsky.

    PMID: 20954435BACKGROUND
  • Kleim JA, Hogg TM, VandenBerg PM, Cooper NR, Bruneau R, Remple M. Cortical synaptogenesis and motor map reorganization occur during late, but not early, phase of motor skill learning. J Neurosci. 2004 Jan 21;24(3):628-33. doi: 10.1523/JNEUROSCI.3440-03.2004.

    PMID: 14736848BACKGROUND
  • Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

    PMID: 3670870BACKGROUND
  • Woby SR, Roach NK, Urmston M, Watson PJ. Psychometric properties of the TSK-11: a shortened version of the Tampa Scale for Kinesiophobia. Pain. 2005 Sep;117(1-2):137-44. doi: 10.1016/j.pain.2005.05.029.

    PMID: 16055269BACKGROUND
  • Bowling A, Hankins M, Windle G, Bilotta C, Grant R. A short measure of quality of life in older age: the performance of the brief Older People's Quality of Life questionnaire (OPQOL-brief). Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):181-7. doi: 10.1016/j.archger.2012.08.012. Epub 2012 Sep 19.

    PMID: 22999305BACKGROUND
  • Wall JC, Bell C, Campbell S, Davis J. The Timed Get-up-and-Go test revisited: measurement of the component tasks. J Rehabil Res Dev. 2000 Jan-Feb;37(1):109-13.

    PMID: 10847578BACKGROUND
  • Sengupta T, Paul B, Banerjee A, Das R, Halder R. Chronic musculoskeletal pain among elderly individuals in a rural area of West Bengal: A mixed-method study. Malays Fam Physician. 2023 Apr 19;18:25. doi: 10.51866/oa.232. eCollection 2023.

MeSH Terms

Conditions

Chronic Pain

Interventions

ExerciseMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants will not be informed whether they are in the experimental or control group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The participants will assigned to the experimental or control group by randomization method. Each group will include in an exercise program for 6 weeks, 2 sessions per week, each session for an average of 60 minutes. The exercise program of the experimental group consist of a combination of a 10-minute warm-up period with graded walking, mobility and stretching exercises, a 20-minute proprioceptive exercise program, a 20-minute nbpet using a laser pointer, and stretching and relaxation exercises that ended with a 10-minute cool-down period. Control group's exercise program consist of a 10-minute warm-up period with graded walking, mobility and stretching exercises, followed by a 40-minute proprioceptive exercise program and a 10-minute cool-down period consisting of stretching and relaxation exercises.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

July 25, 2024

First Posted

August 15, 2024

Study Start

June 3, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations