NCT06803212

Brief Summary

This study was conducted to investigate the effects of dual-task training on upper extremity motor functions in patients with Parkinson's disease. A total of 32 patients participated in the study. Patients were divided into two groups by randomization. One group received only conventional physiotherapy applications, while the other group performed dual-task exercises in addition. Dual-task exercises were performed while conventional treatment was applied. The treatment program was applied as 60x5x6 min/day/week. Conventional treatment was determined according to the individual needs of the patients, including the lower and upper extremities. Dual-task interventions included performing such as counting backward, word recall, and reading words backward. Assessments were repeated twice: Baseline and after a 30-session. "Demographic Information", "Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)", "Box and Block Test" and "Parkinson Disease Questionnaire (PDQ-39) were used as assessment tools.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 27, 2025

Last Update Submit

January 30, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS):

    The scale consists of four separate domains. The first section includes non-motor experiences in daily life (13 items), the second section includes motor experiences in daily life (13 items), the third section involves motor examination (33 items), and the last section addresses motor complications (6 items). The scale contains 65 individual items in total. Items are generally scored between 0-4, with some Yes/No items. The domains of the scale directly related to the upper extremities, including eating, dressing, cleaning, writing, rigidity, finger movements, hand movements, pronation and supination of the hand, postural tremor in the hands, kinetic tremor in the hands, resting tremor, and tremor persistence, were used in this study (Figure 1). The MDS-UPDRS scoring was performed while patients were in the "ON" state.

    Baseline of the study

  • Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS):

    The scale consists of four separate domains. The first section includes non-motor experiences in daily life (13 items), the second section includes motor experiences in daily life (13 items), the third section involves motor examination (33 items), and the last section addresses motor complications (6 items). The scale contains 65 individual items in total. Items are generally scored between 0-4, with some Yes/No items. The domains of the scale directly related to the upper extremities, including eating, dressing, cleaning, writing, rigidity, finger movements, hand movements, pronation and supination of the hand, postural tremor in the hands, kinetic tremor in the hands, resting tremor, and tremor persistence, were used in this study (Figure 1). The MDS-UPDRS scoring was performed while patients were in the "ON" state.

    End of the 30th physiotherapy session

Secondary Outcomes (5)

  • Box Block Test (BBT)

    Baseline of the study

  • Box Block Test (BBT)

    End of the 30th physiotherapy session

  • Parkinson's Disease Questionnaire - 39 (PDQ-39)

    Baseline of the study

  • Parkinson's Disease Questionnaire - 39 (PDQ-39)

    End of the 30th physiotherapy session

  • Demographic Data Form

    Baseline of the study

Study Arms (2)

Conventional Therapy

ACTIVE COMPARATOR

This group were performed just conventional physiotherapy.

Other: Conventional Physiotherapy Program

Dual-Task Interference

EXPERIMENTAL

Dual-task exercises were applied during conventional physiotherapy practices.

Other: Conventional Physiotherapy ProgramOther: Dual-Task Interference

Interventions

The patients' conventional physiotherapy program included stretching, strengthening, balance, and coordination exercises according to their individual needs

Conventional TherapyDual-Task Interference

This intervention consisted of counting backward, reading words backward, and remembering word exercises.

Dual-Task Interference

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 50-85 years with a diagnosis of Stage 1-3 Parkinson's disease, based on the Hoehn \& Yahr Scale
  • Patients had to have no issues with performing basic mathematical operations, - A Mini-Mental State Examination (MMSE) score above 24 points,
  • Regular medication use for at least 4 weeks (for patients who were prescribed medical treatment),
  • No comorbid neurological, neuromuscular, or orthopedic diseases

You may not qualify if:

  • Patients with vision or hearing impairments,
  • Moderate-to-severe fluctuations in tremor or dyskinesia,
  • Having deep brain stimulator implants, or sensory loss in the upper extremities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Tıp Merkezi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor (PhD)

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

June 28, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations