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Telerehabilitation After Spine Surgery

27 agosto 2026 aggiornato da: Kuopio University Hospital

Telerehabilitation as a Method of Rehabilitation Instructions After Spinal Decompression Surgery

The goal of this randomized clinical trial is to assess how different methods of delivering post-operative instructions affect the participants' recovery after spinal decompression surgery. In addition, the investigators evaluate the related healthcare costs and the use of healthcare services in both working-age and elderly populations. The main research questions of the study are:

  1. Does the method or timing of post-operative information influence healthcare utilization or recovery after surgery?
  2. Are telerehabilitation methods easily accessible and usable for the elderly population?
  3. Does early intervention provided in the hospital lead to different recovery times after surgery?

The outcome measures include pain levels, daily activity levels, and healthcare utilization. The results will be compared between study groups based on the information delivery method and age group.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

300

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Kuopio, Finlandia
        • Reclutamento
        • Kuopio University Hospital
        • Contatto:
        • Sub-investigatore:
          • Jannina Koponen
        • Investigatore principale:
          • Janne Pesonen

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • One-level spinal condition requiring decompression surgery
  • Working-age group: 20-65 years; Elderly group 65-85 years
  • Willing to participate

Exclusion Criteria:

  • Malignant disease under active treatment
  • Other disease affecting spine (for example ankylosing disease or vertebral fracture)
  • Opioid or other substance dependancy

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Working-aged spinal decompression, one-level, ppt
Patient receives physiotherapy personally after surgery while leaving hospital
Physiotherapist gives the patient rehabilitation instructions after surgery when the subject leaves hospital
Sperimentale: Working-aged spinal decompression, one-level, tele
Patient receives telerehabilitation personally after surgery 5-7 days
Rehabilitation instrucions given by physiotherapist 4-7 days after surgery with remote telerehabilitation method
Comparatore placebo: Working-aged spinal decompression, one-level, nurse
Patient receives nurse's instructions personally after surgery while leaving hospital
Nurse gives the patient rehabilitation instructions after surgery when the subject leaves hospital
Sperimentale: Elderly spinal decompression, one-level, tele
Patient receives telerehabilitation personally after surgery 5-7 days
Rehabilitation instrucions given by physiotherapist 4-7 days after surgery with remote telerehabilitation method
Sperimentale: Elderly spinal decompression patient, one-level, hpt
Patient receives physiotherapy personally after surgery at hospital outpatient clinic
Physiotherapist gives the patient rehabilitation instructions at the hospital outpatient clinic after 4-7 days post-operatively
Comparatore attivo: Elderly spinal decompression patient, one-level, ppt
Patient receives physiotherapy personally after surgery when leaving the
Physiotherapist gives the patient rehabilitation instructions after surgery when the subject leaves hospital

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain after surgery
Lasso di tempo: From enrollment to 1 year
Pain level / numerical rating scale, range 0-10 where 0 is no pain and 10 is most severe pain imaginable
From enrollment to 1 year
Function after surgery
Lasso di tempo: From enrollment and surgery to 12months after surgery

Function/disability after surgery: investigators assess participants' function and disability by Roland-Morris Disability Questionnaire (RMDQ). RMDQ is a 24-item self-report questionnaire about how low-back pain affects functional activities.

Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).

From enrollment and surgery to 12months after surgery
Disability after surgery (Oswestry Disability Index, ODI)
Lasso di tempo: From enrollment to 12 months after surgery

Oswestry Disability Index (ODI) is a tool used to assess the impact of low back pain on daily functioning. It consists of a questionnaire with 10 questions that evaluate various aspects of daily activities, such as movement, sitting, standing, and sleeping. Each question is scored on a scale from 0 to 5, where 0 indicates no restrictions and 5 indicates significant restrictions. The total score is calculated by summing the scores from the questions, and the higher the score, the greater the impact of the condition on daily life.

Common interpretation ranges include: 0-20 Normal or minimal disability; 21-40 Moderate disability; 41-60 Severe disability; 61-80 Disability that significantly restricts daily activities; 81-100 Bed bound or symptoms may be exaggerated

From enrollment to 12 months after surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Daily activity level after surgery
Lasso di tempo: From enrollment to 1 year after operation
Daily amount of steps, as measured with Garmin wearable activity tracker. Investigatos get the steps taken per day from the device as well as activity index measured by the device.
From enrollment to 1 year after operation
Overall health
Lasso di tempo: From enrollment to surgery and 12 months post-op
Overall health EuroQol 5D questionnaire: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: (1) no problems, (2) slight problems, (3) moderate problems, (4) severe problems and (5) extreme problems. Each category is measured by above levels independently. The 5 dimensions' points do not combine as a sum score.
From enrollment to surgery and 12 months post-op
Overall Health / EuroQol VAS
Lasso di tempo: From enrollment to 12 months post-operative
The EuroQol Visual Analog Scale (EQ VAS) records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. EQ VAS range is 0-100 where 0 represents worst health the participant can imagine and 100 best health imaginable
From enrollment to 12 months post-operative
Contacts to healthcare provider
Lasso di tempo: From enrollment and surgery to 12months after surgery
How many times a participant needs to contact a healthcare provider
From enrollment and surgery to 12months after surgery
Satisfaction to treatment and post-op rehabilitation
Lasso di tempo: From enrollment to 12 months post-op
Satisfaction to post-op rehabilitation, asked by questionnaire by multiple YES/NO questions about the surgery and recovery period. The questions include "I am satisfied to the outcome of the operation", "I would still undergo the operation if I was able to decide now", "The operation helped to my radiculopathy", "I am happy for the rehabilitation I received after the surgery", "The physiotherapy and rehabilitation advice has been sufficient after the surgery", ...
From enrollment to 12 months post-op
Function after operation
Lasso di tempo: From enrollment to 12 months post-operative
Oswestry Disability Index (ODI)
From enrollment to 12 months post-operative
6-minute walking test
Lasso di tempo: From enrollment and surgery to 12months after post-op
On elderly people's research arm, investigators assess participants' physical fitness with 6-minute walking test. Investigators observes and takes time when patient walks 6 minutes in a controlled setting and the total distance covered is measured (meters).
From enrollment and surgery to 12months after post-op
Timed up and go test (3 meters distance)
Lasso di tempo: From enrollment and surgery to 12months after post-op

A 3-meter distance is marked on the floor, with sufficient free space at the end to allow the person to turn around with an assistive device (e.g. a rollator). The front legs of the chair are positioned immediately behind the starting line. The test is performed while wearing shoes.

The person being tested sits in the chair with their back against the backrest and their arms resting on the armrests. If necessary, a mobility aid may be kept within reach and ready for use. When the tester gives the starting command ("Ready - go"), the person stands up, walks at a comfortable and safe pace beyond the line marking the 3-meter distance, ensuring that both feet cross the line, turns around, walks back, and sits down in the chair.

The time is measured to the nearest 0.01 seconds. The tester starts the timer with the command "Go." The timer is stopped when the person being tested has sat back down in the chair, with their buttocks touching the seat.

From enrollment and surgery to 12months after post-op
Walking speed
Lasso di tempo: From enrollment and surgery to 12 months postoperatively
Tested on elderly participants' arm. A 4-meter starting line and finish line are marked on the floor with tape. The test begins from a standing position behind the starting line and ends when the participant's body crosses the finish line. After the command "Go," the participant walks the marked distance twice at their usual pace, and the third time the participant walks the distance more as quickly as possible. The walking time is measured for all three trials to the nearest 0.01 seconds. The tester starts the timer with the command "Go." The timer is stopped when the participant's body crosses the finish line. From these the average is calclulated (m/s)
From enrollment and surgery to 12 months postoperatively
Grip strength
Lasso di tempo: From enrollment and surgery through 12 months postoperatively

On elderly participants' arm, maximum grip strength is measured using a hand dynamometer. During the test, the participant grips the dynamometer handle firmly, gradually increasing the force throughout the trial until maximum grip strength is reached. Each grip is maintained for 3-5 seconds. The position of the shoulder, elbow, and wrist joints must remain unchanged throughout the trial.

The measurement unit is kilograms (kg), as indicated on the outermost scale of the dynamometer display. After the grip is released, the needle remains at the maximum value reached during the trial. Before each subsequent grip, the display is reset to zero using the screw located in the center of the display.

From enrollment and surgery through 12 months postoperatively
Balance
Lasso di tempo: From enrollment and surgery through 12 months postoperatively

Measured on elderly participants' arm: Balance is assessed in three different positions: feet together, in a semi-tandem stance, and in a tandem stance. The participant may use a nearby table for support while positioning their feet into the required test position. Once the position has been achieved, the participant is instructed to release their hands from the support, after which the tester starts the timer.

The time is measured to the nearest 0.01 seconds. The tester starts the timer with the command "Go." The timer is stopped after 10 seconds have elapsed or if the participant's feet move out of the required test position or if they use their hands for support.

From enrollment and surgery through 12 months postoperatively

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Direttore dello studio: Janne Pesonen, MD, PhD, Kuopio University Hospital; Department of Rehabilitation

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2025

Completamento primario (Stimato)

1 dicembre 2029

Completamento dello studio (Stimato)

1 dicembre 2029

Date di iscrizione allo studio

Primo inviato

5 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 agosto 2026

Primo Inserito (Effettivo)

31 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • KUH5960456

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

European Union Data Protection Regulations are very strict. Also, ethical committee prevents the data sharing unless absolutely necessary, and on which occasion the data request must be independently assessed

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .