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Training Based On Declarative Memory Cues Improved Gait In Patients With Parkinson's Disease

6 novembre 2015 aggiornato da: University of Sao Paulo General Hospital

Improvement In Gait Performance After Training Based On Declarative Memory Cues In Patients With Parkinson's Disease: A Randomized Clinical Trial

Deficits in automatic motor control, characteristic of Parkinson's disease (PD), contribute to progressive impairment in gait performance. The use of declarative memory cues in order to promote the engagement of attention and activation of the next movement in gait may minimize the consequences of lack of automatic control. The purpose of this study is to verify the long-term efficiency of a new strategy based on declarative memory cue to improve the gait performance and independence in daily life activities (DLA) in patients with PD.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Background: Deficits in automatic motor control, characteristic of Parkinson's disease (PD), contribute to progressive impairment in gait performance. The use of declarative memory cues in order to promote the engagement of attention and activation of the next movement in gait may minimize the consequences of lack of automatic control.

Objectives: To verify the long-term efficiency of a new strategy based on declarative memory cue to improve the gait performance and independence in daily life activities (DLA) in patients with PD.

Design: Parallel prospective, single blind, randomized clinical trial. Setting: Brazilian Parkinson Association. Participants: Forty-four patients with PD in stages 2-3 of disease evolution according to Hoehn and Yahr Classification Interventions: The experimental training (ET) consisted of eight gait training sessions, twice a week, using the declarative memory cues strategy (DMCS). The control training (CT) consisted of a similar gait training without DMCS.

Primary outcome measure: Gait performance in terms of speed and stride length. Secondary outcome measure: Independence in DLA according to Section II of the Unified Parkinson's Disease Rating Scale.

Randomization: Participants were randomized into a control group (CG), which performed the CT, and an experimental group (EG), which performed the ET, through blinded drawing of names.

Statistical analysis: The gait performance and ADL independence before, 2 and 60 days after the end of training were compared for CG and EG using Repeated-measures analysis of variance (RM-ANOVA).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

50

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

  • Brasile
      • São Paulo, Brasile, 05360-160
        • Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

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 65 anni a 80 anni (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • diagnosis of idiopathic Parkinson's disease according to the UK Brain Bank criteria;
  • in stage 2-3 of the disease evolution according to the Hoehn and Yahr;
  • treated with levodopa or its synergists;
  • capable to ambulate independently indoors without aid;
  • referring 5 to 15 years of education;
  • good visual and auditory acuity.

Exclusion Criteria:

  • presence of other neurological (excluding PD), orthopedic or cardiopulmonary problems;
  • visual and auditory deficiency;
  • dementia [assessed by the Mini Mental State Examination (MMSE), cut-off 23];
  • depression [according to the Geriatric Depression Scale (GDS-15), cut-off 6]
  • participation in other physical therapy training.

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: experimental group (EG)
The experimental training (ET) consisted of eight gait training sessions, twice a week, using the declarative memory cues strategy (DMCS).
Comportamentale: Experimental Training

The ET consisted of 3 phases being that the first one (Phase 1) was done only in the first session.

Phase 1: patients received a short and simple explanation about the deficiency in automatic movement resulting from PD. Following explanation, the patient memorized a sequence of declarative cues. Phase 2: the patient organized a sequence of cues using cards illustrating the subcomponent movements (key movement) involved in taking steps.

Phase 3: the patient had to train using declarative cues as a gait performance aid through 8 sets follow the instruction "Walk in your ordinary speed. Use the key movements and going to saying each of them while you make them. The declarative cues had to be evoked verbally by the patients themselves, during gait, triggering the corresponding movement.

Altri nomi:
  • Declarative memory cues strategy (DMCS)
Comparatore attivo: control group (CG)
The control training (CT) consisted of a similar gait training without DMCS.
Comportamentale: Control Training

The CT consisted of 3 phases, being the first one (Phase 1) was done only in the first session of training, and the other two (Phase 2 and 3) were repeated at each of the 8 sessions.

Phase 1: Patients received a short and simple explanation about the deficiency in automatic movement resulting from PD.

Phase 2: Patients received a general verbal attentional instruction of "pay attention to your steps and try to walk as better as you can", before starting the walk.

Phase 3: motor training of gait, where the patient had to perform 8 sets, following the instruction "Walk in your ordinary speed, paying attention to your steps" in the identical trajectories of ET. Additional instructions or cues were not provided.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
gait speed
Lasso di tempo: up to 3 months
The first primary outcome was the gait speed (m/s). Patients were asked to walk in a straight trajectory of 20 meter following the sole instruction "upon the go signal, walk as fast as possible at the line and stop". The speed was calculated based on the time to walk 20 meters timed using a digital chronometer.
up to 3 months
stride length on gait
Lasso di tempo: up to 3 months
The second primary outcome was the stride length (cm) on gait. Patients were asked to walk in a straight trajectory of 20 meter following the sole instruction "upon the go signal, walk as fast as possible at the line and stop". The number of steps was measured using a pedometer.
up to 3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Independence in activities of daily living (ADL)
Lasso di tempo: up to 3 months
The secondary outcome was independence in activities of daily living (ADL), assessed by Section II of the Unified Parkinson Disease Rating Scale (UPDRS-II). This section includes 12 questions (items 5 to 16) on patient's performance in ADL. Among these questions, two investigate gait performance (frequent fall due to freezing; inability to walk ), with scores ranging from zero (normal) to 4.
up to 3 months

Collaboratori e investigatori

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

Sponsor

University of Sao Paulo General Hospital

Investigatori

  • Investigatore principale: Maria Elisa P Piemonte, PhD, Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

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

1 marzo 2014

Completamento primario (Effettivo)

1 agosto 2015

Completamento dello studio (Effettivo)

1 ottobre 2015

Date di iscrizione allo studio

Primo inviato

4 novembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

6 novembre 2015

Primo Inserito (Stima)

9 novembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

9 novembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 novembre 2015

Ultimo verificato

1 novembre 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • USPNEC006

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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