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Cortical Priming to Optimize Gait Rehabilitation Post Stroke

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University of Illinois

Status

Completed

Conditions

Stroke

Treatments

Other: AMT
Other: tDCS
Behavioral: Treadmill training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03492229
R01HD075777 (U.S. NIH Grant/Contract)
2011-0676

Details and patient eligibility

About

Over four million stroke survivors currently living in the United States are unable to walk independently in the community. To increase the effectiveness of gait rehabilitation, it is critical to develop therapies that are based on an understanding of brain adaptations that occur after stroke. This project will be the first step towards the development of a novel therapeutic approach using brain stimulation to increase walking capacity in stroke survivors and understand the neural mechanisms that are associated with impairment and functional recovery.

Enrollment

81 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 50 - 80 years
  • First ever monohemispheric stroke > 6 months since onset
  • Residual hemiparetic gait deficits
  • Able to walk without an ankle orthotic for 5 minutes at self-paced speed. Handheld assistive device is acceptable.

Exclusion criteria

  • Severe osteoporosis
  • Contracture-limiting range of motion of lower limb
  • Uncontrolled anti-spasticity medications during the study period
  • Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
  • Unhealed decubiti, persistent infection
  • Significant cognitive or communication impairment (MMSE <21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the tracking task.
  • Lesions pertaining to the brainstem and cerebellum

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

81 participants in 4 patient groups

tDCS+AMT
Experimental group
Description:
TDCS in combination with movement training before treadmill training
Treatment:
Other: tDCS
Behavioral: Treadmill training
Other: AMT
tDCS
Active Comparator group
Description:
tDCS only before treadmill training
Treatment:
Other: tDCS
Behavioral: Treadmill training
AMT
Active Comparator group
Description:
Movement training only before treadmill training
Treatment:
Behavioral: Treadmill training
Other: AMT
Control
Sham Comparator group
Description:
No priming before treadmill training
Treatment:
Behavioral: Treadmill training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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