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Effects of Home-based Program in Improving Sitting Balance and Upper Limb Functions in Patients With Stroke

11. juli 2018 opdateret af: Shamay Ng, The Hong Kong Polytechnic University

A Home-Based Program of Transcutaneous Electrical Nerve Stimulation and Task-Related Trunk Training Improves Trunk Control in Patients With Stroke: A Randomized Controlled Clinical Trial

The investigators hypothesize that application of electrical stimulation would augment the effects of exercises in patients with stroke. Combined electrical stimulation with exercises for 6 weeks would lead to earlier and greater improvement in motor functions when compared with placebo-stimulation with exercises.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Previous studies have shown that repeated sensory inputs from transcutaneous electrical stimulation (TES) could enhance brain plasticity and conical motor output. Home-based rehabilitation is shown to be effective in motor recovery and improvement of functional ability in stroke rehabilitation.

The aim of this study was to develop a home-based rehabilitation program to investigate whether combined electrically induced sensory inputs through TES with task-related trunk training (TRTT) in a home-based program would induce earlier and/or greater improvement in, seated reaching distance and trunk control when compared with placebo TES and TRTT, or control with no active treatment in subjects with chronic stroke.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

37

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Diagnosis with first stroke for more than 6 months
  2. Discharge from all rehabilitation services
  3. Ability to understand and follow commands
  4. A carer able for helping the home program
  5. No contraindication to assessment protocol and training

Exclusion Criteria:

  1. Cognitive disorder with Abbreviated Mental Test less than 7
  2. Unilateral neglect with Star cancellation Test less than 47
  3. Sensory deficit
  4. Unable to give informed consent
  5. Unable to speak either Cantonese or English or Mandarin
  6. Commodity that preclude them from undergoing training and assessment
  7. Neurological disease other than stroke

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: electrical stimulation with exercises
The TENS + TRTT group received TENS simultaneously with the TRTT at home under the instruction of a physical therapist.
Adfærdsmæssigt: electrical stimulation with exercises
electrical stimulation with exercises
Placebo komparator: placebo stimulation with exercises
The TENS + TRTT group received placebo-simultaneously with the TRTT at home under the instruction of a physical therapist.
Adfærdsmæssigt: placebo stimulation with exercises
placebo stimulation with exercises
Ingen indgriben: Control
Subjects in this group did not receive any active training. Home safety advice and health education including diet control and blood pressure monitoring were given to the subjects during the home-visit and telephone follow-up.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trunk Impairment Scale
Tidsramme: baseline, 6 weeks
The Trunk impairment scale is a 2 to 4-point ordinal scale. The scale assesses static and dynamic sitting balance and trunk coordination. The maximum scores on the static sitting balance, dynamic sitting balance, and coordination subscales are 7, 10, and 6 points, respectively. The total score of Trunk impairment scale ranges between 0 and 23 points, with a higher score representing better trunk control. The static sitting balance subscale evaluated the trunk stability with both feet on the floor and with the legs crossed. The dynamic sitting balance subscale evaluated the ability to perform trunk side flexion. The coordination components evaluated the ability to selectively rotate the upper and lower parts of the trunk.
baseline, 6 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forward Sitting Functional Reach Test
Tidsramme: baseline, 6 weeks
Sitting Functional Reach was used to assess the limits of stability in reaching activities. The sitting functional reach test measures how far forward, from a sitting position, a subject can bend forward to reach without losing his/her balance. A longer reaching distance indicated a better trunk control.
baseline, 6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Hong Kong Polytechnic University

Efterforskere

  • Ledende efterforsker: Shamay NG, PhD, The Hong Kong Polytechnic University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2010

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

31. december 2014

Datoer for studieregistrering

Først indsendt

10. september 2010

Først indsendt, der opfyldte QC-kriterier

10. september 2010

Først opslået (Skøn)

13. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DHSC_NG
  • DHSC_NG_001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med electrical stimulation with exercises

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner