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Turning Dysfunction After Stroke: Assessment and Intervention

13 dicembre 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

42

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.

Luoghi di studio

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

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

Da 20 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

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: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Trunk exercise group
Participants received trunk exercise for 30 minutes per session, twice a week for 12 weeks.
Altro: 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.
Nessun intervento: Control group
Participants remained their regular activities.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in turning duration at Week 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in trunk range of motion at Week 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Modified Clinical Test of Sensory Integration and Balance at Week 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Collaboratori

Taipei Medical University

Investigatori

  • Investigatore principale: Pei-Jung Liang, Taichung Tzu Chi Hospital

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)

13 luglio 2020

Completamento primario (Effettivo)

31 ottobre 2020

Completamento dello studio (Effettivo)

31 ottobre 2020

Date di iscrizione allo studio

Primo inviato

8 dicembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

13 dicembre 2020

Primo Inserito (Effettivo)

16 dicembre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 dicembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 dicembre 2020

Ultimo verificato

1 dicembre 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 08-XD-051

Piano per i dati dei singoli partecipanti (IPD)

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

NO

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 .

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