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Turning Dysfunction After Stroke: Assessment and Intervention

13. december 2020 opdateret af: Pei Jung Liang, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Turning Dysfunction After Stroke And Its Association To Trunk Control: Underlying Mechanisms And Training Effects

The study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on turning performance, trunk control and motor function in stroke patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study has two parts. The first part is a cross-sectional observatory study.Eligible stroke and healthy subjects are asked their demographic data and assessed for turning performance (stepping patterns and electromyography data of trunk muscles), trunk control (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor function (recovery of extremities and balance function). The second part is a randomized controlled trial. Stroke participants are randomly allocated into trunk exercise and control groups. Trunk exercise group receives trunk exercise including trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks while control group remains their regular activities. Turning performance, trunk control and motor function are evaluated before and after training session.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Taiwan
      • New Taipei City, Taiwan
        • Taipei Tzu Chi Hospital

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

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • age between 20 and 80 years old
  • survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study
  • able to walk independently over a distance of 10 m without walking aids or orthoses
  • able to provide informed consent and follow instructions.

Exclusion Criteria:

  • having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment
  • having cognitive problems with a Mini-Mental State Examination score less than 24 or aphasia that could prevent subjects from following instructions.

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: Trunk exercise group
Participants received trunk exercise for 30 minutes per session, twice a week for 12 weeks.
Andet: Trunk exercise
Trunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks.
Ingen indgriben: Control group
Participants remained their regular activities.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in turning duration at Week 12
Tidsramme: Baseline and Week 12
Turning duration (s) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Longer duration represents poorer turning performance.
Baseline and Week 12
Change from Baseline in turning angular velocity at Week 12
Tidsramme: Baseline and Week 12
Angular velocity (m/s2) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Slower angular velocity represents instability during turning.
Baseline and Week 12
Change from Baseline in trunk muscles electromyography during turning at Week 12
Tidsramme: Baseline and Week 12
Muscle activation patterns (amplitude, % reference voluntary contraction) are observed in bilateral External abdominal oblique (EO) and erector spinae (ES) through an electromyographic analysis. Greater muscle amplitude represents greater muscle contraction.
Baseline and Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in trunk range of motion at Week 12
Tidsramme: Baseline and Week 12
The trunk range of motion (ROM) was measured using a tape measure in sitting position. The spinous processes at C7 and S1 served as landmarks for placement of the tape and measurement for trunk flexion and extension ROM. The length between iliac crest and contralateral acromion of scapula was measured for trunk rotation ROM while the distance between the tip of the middle finger and the floor for trunk lateral flexion ROM. The difference between tape measures in starting and ending positions was calculated for all trunk movement directions. Greater value of trunk flexion and rotation but smaller value of trunk extension and lateral flexion represents better trunk ROM.
Baseline and Week 12
Change from Baseline in trunk muscles strength at Week 12
Tidsramme: Baseline and Week 12
Trunk flexors, extensors, rotators, and lateral flexors strength were measured using a MicroFET3 dynamometer. Participants were asked to generate the maximum trunk flexion, extension, rotation bilaterally and lateral flexion bilaterally for a period of 6 seconds each. Resistance was applied using the dynamometer to obtain the value of each trunk muscle (kg). Greater value represents greater muscle strength.
Baseline and Week 12
Change from Baseline in Trunk Impairment Scale at Week 12
Tidsramme: Baseline and Week 12
Trunk control was assessed by the Trunk Impairment Scale (TIS) which has good inter-rater reliability with intra-class coefficient 0.85-0.99 and internal consistency with Cronbach's α 0.65-0.89. The TIS evaluates static and dynamic sitting balance and trunk coordination in a sitting position. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
Baseline and Week 12

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Modified Clinical Test of Sensory Integration and Balance at Week 12
Tidsramme: Baseline and Week 12
Modified Clinical Test of Sensory Integration and Balance (mCTSIB) is designed to assess how well an older adult is using sensory inputs when one or more sensory systems are compromised. The postural sway was measured in 4 sensory conditions through visual and proprioceptive manipulation using APDM Opal wireless sensors. The greater postural sway represents the poorer balance.
Baseline and Week 12
Change from Baseline in Berg Balance Scale at Week 12
Tidsramme: Baseline and Week 12
The Berg balance scale (BBS) is used to objectively determine a participant's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. The total score is 56.
Baseline and Week 12
Change from Baseline in Timed Up and Go test at Week 12
Tidsramme: Baseline and Week 12
Function mobility was assessed by the Timed Up and Go (TUG) test. Participants were instructed to stand up from a chair, walk 3 meters, turn around, and walk back to the chair sit down. Time to complete the task was recorded. The more time taken is representative of the lower level of functional mobility.
Baseline and Week 12

Samarbejdspartnere og efterforskere

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

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Samarbejdspartnere

Taipei Medical University

Efterforskere

  • Ledende efterforsker: Pei-Jung Liang, Taichung Tzu Chi Hospital

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 (Faktiske)

13. juli 2020

Primær færdiggørelse (Faktiske)

31. oktober 2020

Studieafslutning (Faktiske)

31. oktober 2020

Datoer for studieregistrering

Først indsendt

8. december 2020

Først indsendt, der opfyldte QC-kriterier

13. december 2020

Først opslået (Faktiske)

16. december 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. december 2020

Sidst verificeret

1. december 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 08-XD-051

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Trunk exercise

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Betingelser

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Placeringer

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