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

30. august 2018 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

504

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Odense, Danmark, 5000
        • Odense University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
Eksperimentell: 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.
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.
Aktiv komparator: 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.
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
Eksperimentell: 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.
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.
Eksperimentell: 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.
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.
Aktiv komparator: 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.
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2014

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

1. desember 2017

Datoer for studieregistrering

Først innsendt

21. mars 2014

Først innsendt som oppfylte QC-kriteriene

27. mars 2014

Først lagt ut (Anslag)

28. mars 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • REHAB123

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