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Wearable Device Guided Exercise for Patients on Total Knee Arthroplasty Wait-list

27 oktober 2026 uppdaterad av: Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong

The Application of Wearable Device Guided Pre-operative Exercise Programme for Patients Awaiting Total Knee Arthroplasty: A Randomized Controlled Trial

Total knee arthroplasty (TKA) is a cost effective solution for people with end-stage knee osteoarthritis. Given Hong Kong's large senior population and age as the primary risk factor for osteoarthritis, waiting times for total knee arthroplasty can reach 30 months. To manage this long wait list, patients would be enrolled to a structured exercise program with group and home based exercise. Currently limited options are available for home based exercise adherence monitoring for TKA patients on the wait-list. This study will assess the effect of wearable device with smartphone application to guide home based exercise among these wait-list patients. The main hypothesis is that the use of wearable device will decrease patient's pain level and improve their physical activity level.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

All participants will consent that their anonymized data will be collected and used for scientific publications in accordance to the declaration of Helsinki. Patients on the wait-list for primary TKA at Prince of Wales Hospital in Hong Kong would be recruited and randomized to either wearable device or control group with measurements done at baseline, six weeks and six months post intervention. Control group received standard training intervention and follow up schedules, while the wearable device group would receive the wearable device and associated smartphone application along with familiarization training over the first six weeks of training.

Studietyp

Interventionell

Inskrivning (Beräknad)

106

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • end-stage knee osteoarthritis according to European Alliance of Associations for Rheumatology
  • Radiographic evidence of joint damage
  • Significant functional limitations
  • Severe knee pain

Exclusion Criteria:

  • Had undergone bilateral TKA,
  • exercise contraindication
  • terminal illness
  • chronic immobility
  • acute myocardial infraction within previous six weeks

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Control

Participants received standardized group and home based intervention with similar measurement time points and exercise prescription as the intervention

Participants received home based exercise prescription only.

Experimentell: Wearable

Participants received wearable device with complementary smartphone application for exercise monitoring

Participants received the same group and home based exercise prescription, with the same measurement timeline as control group. Participants received wearable device with application for smartphone for home exercise monitoring and familiarization during group training sessions

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Knee Injury Osteoarthritis Outcome Score (KOOS)
Tidsram: baseline, 6 weeks and 6 months

10 minute self completed questionnaire measuring five sub-scales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Each sub-scale scored from 0 to 100, with 100 being no complaints.

baseline, 6 weeks and 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Knee Flexion during walking
Tidsram: baseline, 6 weeks and 6 months

Patients walk and have their knee flexion measured using optical motion capture, outcome in degrees.

baseline, 6 weeks and 6 months
Hip Flexion during walking
Tidsram: baseline, 6 weeks and 6 months

Patients walk and have their hip flexion measured using optical motion capture, outcome in degrees.

baseline, 6 weeks and 6 months
Knee Flexion during sit-to-stand
Tidsram: baseline, 6 weeks and 6 months

Patients does sit-to-stand and have their knee flexion measured using optical motion capture, outcome in degrees.

baseline, 6 weeks and 6 months
Hip Flexion during sit-to-stand
Tidsram: baseline, 6 weeks and 6 months

Patients does sit-to-stand and have their hip flexion measured using optical motion capture, outcome in degrees.

baseline, 6 weeks and 6 months
30 seconds chair to stand test
Tidsram: baseline, 6 weeks and 6 months

Participant sat on on a chair then execute repetitive sit-to-stand movement as much as possible within 30 seconds, outcome in number of repetitions completed.

baseline, 6 weeks and 6 months
Functional Reach Test
Tidsram: baseline, 6 weeks and 6 months

Participant stand with their feet together and legs straight, then try to reach forward as far as possible, outcome in reach distance (centimeter).

baseline, 6 weeks and 6 months
Timed Up and Go Test
Tidsram: baseline, 6 weeks and 6 months

Participant started in seated position, on instruction would stand up, walk forward for three meters, return back to the chair and sit down. Outcome in time (seconds) needed to complete.

baseline, 6 weeks and 6 months
Knee Society Score (KSS)
Tidsram: baseline, 6 weeks and 6 months

Physician assessed questionnaire measuring patient pain, range of motion, stability, and joint alignment, scoring between 0 to 100, with 100 being perfect score.

baseline, 6 weeks and 6 months
Knee Society Functional Score
Tidsram: baseline, 6 weeks and 6 months

Patient self-assessment questionnaire measuring their ability to execute physical activities, scoring between 0 to 100, with 100 being perfect score.

baseline, 6 weeks and 6 months

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

10 november 2026

Primärt slutförande (Beräknad)

30 november 2027

Avslutad studie (Beräknad)

30 juni 2028

Studieregistreringsdatum

Först inskickad

20 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

27 oktober 2026

Första postat (Faktisk)

3 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

only anonymized data can be shared with interested parties as this is clinically sensitive data

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

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Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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