Extracorporeal Shock Wave Therapy Applied to the Plantar Region in Individuals With Hemiplegia

NCT05360316 | Completed

• 1 other identifier: Firat Uni
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sensory and balance losses occur in hemiplegic patients. In some patients, sensory and balance rehabilitations may vary depending on the treatment they receive, depending on the treatment. It is a fact that the affected anatomic neuronal regions can cause different damages for each person together with interneuronal relations. This study aims to sense sensation with Extracorporeal Shock Wave Therapy to be applied to the plantar region.

Conditions

Extracorporeal Shock Wave Therapy; Kinaesthesia; Sensory Disorders

Keywords

Extracorporeal Shock Wave Therapy; Kineaesthesia; Hemiplegia; Deep sense; Superficial sense

Outcome Measures

Primary Outcomes (10)

• Balance

  Berg Balance Scale (BBS): The BBS is a 14-item test of functional balance, with each item rated out of 4 for a total score of 56. It assesses static balance in sitting and standing, as well as dynamic balance during transitions and while in standing. Individuals who are able to maintain their balance for each task score higher on this outcome.

  3 mounths

• Maximum plantar pressure

  The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure maximum plantar pressure

  3 Mounths

• Static posture

  The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure static posture

  3 Mounths

• Step cycle duration

  The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure step cycle duration

  3 Mounths

• Single-support phase

  The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure single-support phase

  3 Mounths

• Swing phase

  The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure swing phase

  3 Mounths

• Step length

  The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure step length

  3 Mounths

• Foot angle

  The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure foot angle

  3 Mounths

• Cadence

  The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure cadence

  3 Mounths

• Gait cycle distance

  The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure

  3 Mounths

Study Arms (2)

ESWT

PLACEBO COMPARATOR

Patients assigned to the ESWT group received ESWT over the plantar fascia, three days/week, for six weeks. In addition patients participated additional in the same conventional stroke rehabilitation program consisting of 60 minutes of treatment a day, five times a week for six weeks (30 sessions). The conventional therapy programs were patient-specific and consisted mainly of physiotherapy, such as neurodevelopmental facilitation techniques, passive mobilization, occupational therapy, postural control exercises, stretching and range-of-motion exercises for the hemiparetic side and balance training.

Device: ESWT

Placebo

NO INTERVENTION

Routine therapy Patients participated in the same conventional stroke rehabilitation program consisting of 60 minutes of treatment a day, five times a week for six weeks (30 sessions). The conventional therapy programs were patient-specific and consisted mainly of physiotherapy, such as neurodevelopmental facilitation techniques, passive mobilization, occupational therapy, postural control exercises, stretching and range-of-motion exercises for the hemiparetic side and balance training.

Interventions

ESWT DEVICE

extracorporeal shock wave therapy

ESWT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever hemiplegia
• Hemiplegia duration of at least 6 months
• Ability to walk alone without an orthosis.

You may not qualify if:

• Patients with ataxia, dystonia, or dyskinesia
• Patients with dementia
• Patients with bilateral hemiplegia
• Taking antispastic drugs

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Furkan Bilek

Elâzığ, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sensation Disorders; Hemiplegia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Officials

• Gulnihal Deniz, Asst. Prof.

  Firat University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled, double blind

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: May 4, 2022
• Study Start: January 4, 2020
• Primary Completion: April 4, 2021
• Study Completion: May 4, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-04

Locations

TU (1)