NCT04734314

Brief Summary

. To investigate the effect of Vojta method on static balance ,dynamic balance, quality of life in patients with chronic non - specific low back pain

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2021

Completed
Last Updated

February 8, 2021

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

January 28, 2021

Last Update Submit

February 4, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • static and dynamic balance

    static and dynamic balance can assessed by using biodex balance system Each patient was instructed to maintain his/her balance for the period of the test. There was report gained after finishing every test includes information on medial lateral stability index(MLSI), overall stability index(OSI), and anterior posterior stability index (APSI) measurements will done twice before and after treatment for all patients in both group

    one month

  • Oswestry Low Back Pain Disability Questionnaire

    The Oswestry Low Back Pain Disability Questionnaire is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability and quality of life. The test is considered the 'gold standard' of low back functional outcome tools measurements will done twice before and after treatment for all patients in both group

    one month

Study Arms (2)

conventional treatment of back pain

EXPERIMENTAL

Group A: received conventional treatment of back pain which included; TENS 20 min and hot packs 10 min .The total treatment session is 30 min three session per week for four weeks

Other: conventional physical therapy

vojta therapy

EXPERIMENTAL

received conventional treatment of back pain in addition to Vojta therapy . The total treatment session is 40 min.

Other: conventional physical therapyOther: vojta therapy

Interventions

conventional physical therapy in the form of transcutaneous electrical stimulation (TENS) for 20 min and hot pack for 10 min Each patient received 12 sessions three session per week.

conventional treatment of back painvojta therapy

Vojta Dynamic Neuromuscular Stabilization (DNS) is a therapy used to manage neurological and musculoskeletal conditions each patient in the study group (group B) was instructed to lie prone on an examination table with the participant's shoulders abducted, elbows flexed approximately 80-90°, and the forearms hanging off the edge of the table. Pressure-like stimulation of the calcaneus and ASIS were performed in the postural position named by Vojta as "reflex creeping. Each patient received 12 sessions three session per week.

vojta therapy

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with chronic non -specific low back pain for more than 3 months.
  • Their age ranged between 18-35 years old
  • Both sexes were recruited in this study.
  • Their BMI ranged between 18-25 kg/m2

You may not qualify if:

  • Patients with previous spinal surgery 2. Patients who have radiological diagnosis of spondylolysis or spondylolisthesis.
  • \. Patient with neurological disease . 4. Chest problems 5. Systematic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mti University

Cairo, Egypt

RECRUITING

Central Study Contacts

walaa mohamed, B.Sc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 2, 2021

Study Start

April 1, 2020

Primary Completion

February 5, 2021

Study Completion

February 5, 2021

Last Updated

February 8, 2021

Record last verified: 2020-04

Locations