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Upper Limb Cross-education in Subacute Stroke

B

Bezmialem Vakif University

Status

Completed

Conditions

Stroke
Hemiplegia

Treatments

Device: EMS
Device: TENS
Procedure: Conventional rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT04113369
2015-16/10

Details and patient eligibility

About

This study evaluates how cross-education (unilateral training) affects muscle strength of the paretic limb in acute stroke patients. Half of the hemiplegic patients will receive conventional treatment and transcutaneous electrical nerve stimulation (TENS) to non-paretic side, while other half will receive conventional treatment and electro muscular stimulation (EMS) to non-paretic side.

Full description

Cross-education, which means the performance improvement in the untrained homologous muscle after unilateral exercise training, is studied in various orthopedical and neurological conditions affecting the body unilaterally. For those with asymmetrical weakness and immobility after stroke, training the non-paretic side can be utilized to increase the strength of the paretic side and improve functional symmetry. In this study, investigators aim was to examine whether training non-paretic upper extremity wrist flexor muscles by EMS in adjunct to conventional training program, has additional benefits upon the muscle powers of the homologous agonist and antagonist muscles. Investigators will use low frequency antalgic TENS stimulation at barely sensible level, which is considered not to cause muscle strengthening, as a control intervention.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • thromboembolic stroke,
  • <6 months of stroke,
  • right hand dominancy,
  • left hemiplegia,
  • Brunnstrom stage ≥ 3 of recovery for upper extremity and hand

Exclusion criteria

  • myopathy, tendinopathy, peripheral neuropathy of the upper extremities,
  • auditory, cognitive or speech disorder that enables communication,
  • history of fracture or arthrodesis in the upper limb,
  • contracture or severe spasticity (Ashworth scale ≥ 2) in forearm muscles,
  • severe cardiovascular disorders (heart failure, coronary artery disease, drug resistant hypertension)

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

TENS group
Sham Comparator group
Description:
30 sessions (5 sessions/week, 6 weeks) of training including 40 minutes of lower limb training including a mixture of lower limb gait training, balance training and aerobic training and a combination of task-oriented treatment, fine motor skill training, range of motion exercises stretch exercises and strength training (75% repetition maximum (RM), 6 repetitions) for 20 minutes. After that training program, patients will receive 30 minutes of conventional antalgic TENS (100 Hz) program as controls with electrostimulation device to the non-paretic wrist flexors.
Treatment:
Device: TENS
Procedure: Conventional rehabilitation
EMS group
Active Comparator group
Description:
0 sessions (5 sessions/week, 6 weeks) of training including 40 minutes of lower limb training including a mixture of lower limb gait training, balance training and aerobic training and a combination of task-oriented treatment, fine motor skill training, range of motion exercises stretch exercises and strength training (75% repetition maximum (RM), 6 repetitions) for 20 minutes. After that training, the patients will receive 20 minutes of electrical stimulation to their non-paretic forearm upon wrist flexors by an intermittent maximum strength program (6 seconds of contraction, 10 seconds of rest) along with 5 minutes of pre and post warm-up with the same device.
Treatment:
Device: EMS
Procedure: Conventional rehabilitation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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