NCT06498453

Brief Summary

The main objective of this clinical trial is to compare the effectiveness of digital physiotherapy treatment using the Trak telerehabilitation platform and the application of conventional means on two different health conditions (mild or moderate knee osteoarthritis and shoulder tendinopathy) Participants will undergo telerehabilitation treatment through the TRAK platform for six weeks (treatment group) or follow the instructions and guidelines collected by health personnel for the same time in face-to-face rehabilitation sessions (control group).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
Last Updated

December 3, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

July 5, 2024

Last Update Submit

December 2, 2024

Conditions

Shoulder InjuryKnee Injury

Keywords

TelemedicineDigital healthTelehealth care

Outcome Measures

Primary Outcomes (2)

  • Escala DASH

    It is used to measure the self-rated upper-extremity disability and symptoms.

    Baseline and six months

  • Escala KOOS-PS

    It evaluates the patient's opinion about their knee and associated problems.

    Baseline and six months

Secondary Outcomes (4)

  • Daniels scale

    Baseline and six months

  • EVA scale

    Baseline and six months

  • Trak designed a satisfaction questionnaire

    Baseline and six months

  • Limb mobility

    Baseline and six months

Study Arms (4)

Knee treatment

EXPERIMENTAL

Use of TRAK platform as a treatment metodology on knee patients

Device: Trak-Physio knee condition

Knee control

ACTIVE COMPARATOR

They did not have access to the platform and were instructed to continue with the standard care program through exercise.

Other: Knee conventional rehabilitation program

Shoulder treatment

EXPERIMENTAL

Use of TRAK platform as a treatment metodology on shoulder patients

Device: Trak-Physio in shoulder condition

Shoulder control

ACTIVE COMPARATOR

They did not have access to the platform and were instructed to continue with the standard care program through exercise.

Other: Shoulder conventional rehabilitation program

Interventions

Trak-Physio knee conditionDEVICE

The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.

Knee treatment
Trak-Physio in shoulder conditionDEVICE

The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.

Shoulder treatment
Knee conventional rehabilitation programOTHER

Exercise protocol with the methodology of conventional clinical practice.

Knee control
Shoulder conventional rehabilitation programOTHER

Exercise protocol with the methodology of conventional clinical practice.

Shoulder control

Eligibility Criteria

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

You may qualify if:

  • Patient over 18 years of age.
  • Patients with musculoskeletal pathology according to:
  • Knee: patients between 50 and 70 years old with a knee injury. Among the injuries Considered include mild or moderate osteoarthrosis and knee meniscopathies.
  • Shoulder: patients with shoulder tendonitis.
  • Patients with a tablet, smartphone or laptop who function agilely with the telematic technology necessary for the study.
  • Have an email account.
  • Understand the purpose of the study.
  • Signing of the informed consent.
  • Commitment to carry out the prescribed treatments.

You may not qualify if:

  • Patients with advanced cognitive impairment.
  • Patients with tendon tears or ruptures, in patients with shoulder tendinopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asunción Klinika

Tolosa, Gipuzkoa, 20400, Spain

Location

Related Publications (10)

  • Anton D, Berges I, Bermudez J, Goni A, Illarramendi A. A Telerehabilitation System for the Selection, Evaluation and Remote Management of Therapies. Sensors (Basel). 2018 May 8;18(5):1459. doi: 10.3390/s18051459.

    PMID: 29738442BACKGROUND

  • Chae SH, Kim Y, Lee KS, Park HS. Development and Clinical Evaluation of a Web-Based Upper Limb Home Rehabilitation System Using a Smartwatch and Machine Learning Model for Chronic Stroke Survivors: Prospective Comparative Study. JMIR Mhealth Uhealth. 2020 Jul 9;8(7):e17216. doi: 10.2196/17216.

    PMID: 32480361BACKGROUND

  • Cottrell MA, Hill AJ, O'Leary SP, Raymer ME, Russell TG. Service provider perceptions of telerehabilitation as an additional service delivery option within an Australian neurosurgical and orthopaedic physiotherapy screening clinic: A qualitative study. Musculoskelet Sci Pract. 2017 Dec;32:7-16. doi: 10.1016/j.msksp.2017.07.008. Epub 2017 Aug 1.

    PMID: 28787636BACKGROUND

  • Cramer SC, Dodakian L, Le V, See J, Augsburger R, McKenzie A, Zhou RJ, Chiu NL, Heckhausen J, Cassidy JM, Scacchi W, Smith MT, Barrett AM, Knutson J, Edwards D, Putrino D, Agrawal K, Ngo K, Roth EJ, Tirschwell DL, Woodbury ML, Zafonte R, Zhao W, Spilker J, Wolf SL, Broderick JP, Janis S; National Institutes of Health StrokeNet Telerehab Investigators. Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Sep 1;76(9):1079-1087. doi: 10.1001/jamaneurol.2019.1604.

    PMID: 31233135BACKGROUND

  • Hosseiniravandi M, Kahlaee AH, Karim H, Ghamkhar L, Safdari R. Home-based telerehabilitation software systems for remote supervising: a systematic review. Int J Technol Assess Health Care. 2020 Apr;36(2):113-125. doi: 10.1017/S0266462320000021. Epub 2020 Mar 10.

    PMID: 32151291BACKGROUND

  • Hung M, Bounsanga J, Voss MW, Saltzman CL. Establishing minimum clinically important difference values for the Patient-Reported Outcomes Measurement Information System Physical Function, hip disability and osteoarthritis outcome score for joint reconstruction, and knee injury and osteoarthritis outcome score for joint reconstruction in orthopaedics. World J Orthop. 2018 Mar 18;9(3):41-49. doi: 10.5312/wjo.v9.i3.41. eCollection 2018 Mar 18.

    PMID: 29564213BACKGROUND

  • Monticone M, Baiardi P, Vanti C, Ferrari S, Pillastrini P, Mugnai R, Foti C. Responsiveness of the Oswestry Disability Index and the Roland Morris Disability Questionnaire in Italian subjects with sub-acute and chronic low back pain. Eur Spine J. 2012 Jan;21(1):122-9. doi: 10.1007/s00586-011-1959-3. Epub 2011 Aug 8.

    PMID: 21823035BACKGROUND

  • Perruccio AV, Stefan Lohmander L, Canizares M, Tennant A, Hawker GA, Conaghan PG, Roos EM, Jordan JM, Maillefert JF, Dougados M, Davis AM. The development of a short measure of physical function for knee OA KOOS-Physical Function Shortform (KOOS-PS) - an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 May;16(5):542-50. doi: 10.1016/j.joca.2007.12.014. Epub 2008 Feb 21.

    PMID: 18294869BACKGROUND

  • Seron P, Oliveros MJ, Gutierrez-Arias R, Fuentes-Aspe R, Torres-Castro RC, Merino-Osorio C, Nahuelhual P, Inostroza J, Jalil Y, Solano R, Marzuca-Nassr GN, Aguilera-Eguia R, Lavados-Romo P, Soto-Rodriguez FJ, Sabelle C, Villarroel-Silva G, Gomolan P, Huaiquilaf S, Sanchez P. Effectiveness of Telerehabilitation in Physical Therapy: A Rapid Overview. Phys Ther. 2021 Jun 1;101(6):pzab053. doi: 10.1093/ptj/pzab053.

    PMID: 33561280BACKGROUND

  • van Egmond MA, van der Schaaf M, Vredeveld T, Vollenbroek-Hutten MMR, van Berge Henegouwen MI, Klinkenbijl JHG, Engelbert RHH. Effectiveness of physiotherapy with telerehabilitation in surgical patients: a systematic review and meta-analysis. Physiotherapy. 2018 Sep;104(3):277-298. doi: 10.1016/j.physio.2018.04.004. Epub 2018 Jun 19.

    PMID: 30030037BACKGROUND

MeSH Terms

Conditions

Shoulder InjuriesKnee Injuries

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg Injuries

Study Officials

  • María A García Velázquez

    Asunción Klinika

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2024

First Posted

July 12, 2024

Study Start

March 1, 2022

Primary Completion

June 6, 2023

Study Completion

June 6, 2023

Last Updated

December 3, 2024

Record last verified: 2024-12

Locations

ES(1)