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The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores

torstai 30. elokuuta 2018 päivittänyt: Alice Ørts Hansen, Odense University Hospital

Background Patients with the same type of hand injury often reach different functional levels. Therefore, it is necessary to investigate what kind of rehabilitation is most efficient for each individual patient.

Research has shown that a person's "Sense of Coherence" (SOC) affects how he /she deals with disease. Furthermore, SOC can help predict final outcomes after orthopedic injuries and should therefore; be taken into consideration when planning rehabilitation. It was concluded in a study that patients with a weak SOC who have had a hand injury, may benefit from extra support to manage their everyday activities in order to reach the same final outcome as patients with a strong SOC.

Purpose To investigate two types of rehabilitation on patients with a hand-related injury (joint mobility exercises vs. activity-based training and joint mobility exercises) and to investigate whether SOC can be used as an indicator of which patients would benefit from activity-based training.

Hypotheses

  1. Patients with a hand-related injury will benefit from activity-based training in their rehabilitation program.
  2. Patients with a weak SOC will achieve the best functional level, if activity-based training is included in their rehabilitation program.
  3. Patients with a strong SOC will not achieve a higher functional level, if activity-based training is included in their rehabilitation program.

Study design Randomised control trial. Methods Four-hundred-twenty- patients age 18 years or older are included when referred to specialized outpatient occupational therapy after a hand-related injury. To ensure sufficient and balanced patient variation in relation to pre-rehabilitation sense of coherence, a balanced randomisation principle has been implemented.

Data will be collected through questionnaires. The questionnaires measure SOC (13 items version), function (DASH), quality of life (EQ5D) and satisfaction.

All participants will perform joint mobility exercises which are appropriate for their injury. In addition, participants who will be performing activity-based training will train with specific meaningful activities which they performed prior to the hand-related injury.

Clinical relevance The knowledge obtained will be incorporated into the planning of occupational therapy rehabilitation services for this patient group, so that the patients will receive the most optimal conditions in which to achieve their previous level of function after a hand injury.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

504

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Tanska
      • Odense, Tanska, 5000
        • Odense University Hospital

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • Patients with hand-related diagnoses (acute injuries or elective surgeries)
  • Patients referred to specialized outpatient occupational therapy rehabilitation at Odense University Hospital
  • Patients who are able to understand, speak and read enough Danish to participate
  • 18-years of age or older

Exclusion Criteria:

  • A rehabilitation treatment period under four weeks and less than three treatments
  • Dementia or cognitive impairments
  • Where it is not considered medically or therapeutically safe to allow the patient to be included in the randomization process.
  • Patients with shoulder problems
  • Patients with epicondylitis
  • Patients with plexus brachialis injuries
  • Patients who only have difficulty extending their non-dominant 5th finger.
  • Burn injuries
  • Pt. who have had a CMP joint replacement operation because of arthrosis (Swanson)

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: strong sense of coherence control group
Patients with a strong sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program.
Muut: Joint mobility exercises hand therapy
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
Kokeellinen: strong sense of coherence intervention
Patients with a strong sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury and specific meaningful activities which they performed prior to the hand-related injury. This will be performed both in the therapy setting and as a home exercise program.
Muut: activity-based hand therapy
intervention involve joint mobility exercises which are appropriate for their injury and training with specific meaningful activities which they performed prior to the hand-related injury. Activity-based hand therapy will be performed both in the therapy setting and as a home exercise program.
Active Comparator: weak sense of coherence control group
Patients with a weak sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program.
Muut: Joint mobility exercises hand therapy
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
Kokeellinen: weak sense of coherence intervention
Patients with a weak sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury and specific meaningful activities which they performed prior to the hand-related injury. This will be performed both in the therapy setting and as a home exercise program.
Muut: activity-based hand therapy
intervention involve joint mobility exercises which are appropriate for their injury and training with specific meaningful activities which they performed prior to the hand-related injury. Activity-based hand therapy will be performed both in the therapy setting and as a home exercise program.
Kokeellinen: medium sense of coherence intervention
Patients with a medium sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury and specific meaningful activities which they performed prior to the hand-related injury. This will be performed both in the therapy setting and as a home exercise program.
Muut: activity-based hand therapy
intervention involve joint mobility exercises which are appropriate for their injury and training with specific meaningful activities which they performed prior to the hand-related injury. Activity-based hand therapy will be performed both in the therapy setting and as a home exercise program.
Active Comparator: medium sense of coherence control group
Patients with a weak sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program.
Muut: Joint mobility exercises hand therapy
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Aikaikkuna
Disabilities of the Arm, Shoulder, and Hand questionnaire
Aikaikkuna: from baseline to 12 months after start of rehabilitation
from baseline to 12 months after start of rehabilitation

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
The EQ-5D Quality of life questionnaire
Aikaikkuna: From baseline to 3 months
From baseline to 3 months
Sense of Coherence Questionnaire
Aikaikkuna: From baseline to 12 months
13 items questionnaire
From baseline to 12 months
Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)
Aikaikkuna: From baseline to 3 months
From baseline to 3 months
Satisfaction with daily living and rehabilitation
Aikaikkuna: From baseline to12 months
From baseline to12 months

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Odense University Hospital

Yhteistyökumppanit

University of Southern Denmark
Region of Southern Denmark
Bevica Fonden
Danish Association of Occupational Therapist

Tutkijat

  • Opintojen puheenjohtaja: Hans B Tromborg, Ph.D, University of Southern Denmark

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Lauantai 1. helmikuuta 2014

Ensisijainen valmistuminen (Todellinen)

Torstai 1. joulukuuta 2016

Opintojen valmistuminen (Todellinen)

Perjantai 1. joulukuuta 2017

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 21. maaliskuuta 2014

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 27. maaliskuuta 2014

Ensimmäinen Lähetetty (Arvio)

Perjantai 28. maaliskuuta 2014

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 31. elokuuta 2018

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 30. elokuuta 2018

Viimeksi vahvistettu

Keskiviikko 1. elokuuta 2018

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • REHAB123

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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Kliiniset tutkimukset Joint mobility exercises hand therapy

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