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Effects of Physical Exercise Combined With Transcranial Direct Current Stimulation in Parkinson's Disease

ConditionParkinson' Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversidad Rey Juan Carlos

About this trial

A controlled, blinded, and randomized clinical study will be carried out in a large sample of people with Parkinson's disease, where the combined effects of physical exercise and transcranial direct curren stimlation (tDCS) on motor function will be evaluated.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • real tDCS and exercise

    Other intervention

    24 sessions of reactive exercise simulatenously with anodal tDCS over the motor cortex contralteral to the most affected side.

  • Sham tDCS and exercise

    Other intervention

    24 sessions of reactive exercise with sham tDCS

  • Exercise

    Other intervention

    24 sessions of reactive exercise

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: realtDCS&exercise GroupExperimental treatment 1 intervention
Group B: shamtDCS&exercise GroupPlacebo comparator 1 intervention
Group C: Exercise GroupActive comparator 1 intervention
Group D: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Gait Speed at Preferred Speed

Gait speed assessed during walking at preferred speed using the OptoGait System. Units m/s

Time frame
From enrollment to the end of treatment at 7 weeks
2

Step length at Preferred Speed

Step length assessed during walking at preferred speed using the OptoGait System. Units meters

Time frame
From enrollment to the end of treatment at 7 weeks
3

Cadence at Preferred Speed

Cadence assessed during walking at preferred speed using the OptoGait System. Units steps/min

Time frame
From enrollment to the end of treatment at 7 weeks
4

Gait Speed at Maximal Speed

Gait speed assessed during walking at maximal speed using the OptoGait System. Units m/s

Time frame
From enrollment to the end of treatment at 7 weeks

Secondary outcomes

1

Grooved pegboard test

Manual dexterity assessed using the Grooved Pegboard test. Participants were instructed to place key-shaped pegs into a grooved board as quickly as possible using one hand. Performance was defined as the time required to correctly place all pegs into the board, expressed in seconds. Lower completion times indicate better manual dexterity.

Time frame
From enrollment to the end of treatment at 7 weeks
2

Path Length With Eyes Open Without Cognitive Task

Center of pressure path length, expressed in millimeters, assessed using force platform posturography during quiet standing with eyes open and without a concurrent cognitive task. Higher values indicate poorer postural stability. Units millimeter

Time frame
From baseline to the end of treatment at 7 weeks
3

Path Length With Eyes Closed Without Cognitive Task

Center of pressure path length, expressed in millimeters, assessed using force platform posturography during quiet standing with eyes closed and without a concurrent cognitive task. Higher values indicate poorer postural stability. Units millimeter

Time frame
From baseline to the end of treatment at 7 weeks
4

Path Length With Eyes Open With Cognitive Task

Center of pressure path length, expressed in millimeters, assessed using force platform posturography during quiet standing with eyes open and with a concurrent cognitive task. Higher values indicate poorer postural stability. Units millimeter

Time frame
From baseline to the end of treatment at 7 weeks

Other outcomes

Sponsors and contacts

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Universidad Rey Juan Carlos

Lead sponsor

Source ClinicalTrials.gov
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