NCT05170776

Brief Summary

to investigate the Efficacy of adding Pilates to postural correction exercise on nerve root function and electromyography activity in symptomatic forward head posture: Randomized Controlled Trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 11, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

December 11, 2021

Last Update Submit

August 5, 2022

Conditions

Keywords

forward head psturePilates exercisepostural correction exercisenerve root function

Outcome Measures

Primary Outcomes (1)

  • nerve root function

    nerve root function in the form of somatosensory evoked potential will be measure by electromyograph.

    up to ten weeks

Secondary Outcomes (5)

  • pain intensity

    up to ten weeks

  • neck disability

    up to ten weeks

  • flexion and extension endurance test

    up to ten weeks

  • muscle amplitude

    up to ten weeks

  • craniovertebral angle

    up to ten weeks

Study Arms (3)

Pilates and postural correction exercise

EXPERIMENTAL

pilates and postural correction exercise will be received three times a week for 10 weeks

Other: Pilates and postural correction exercise

Pilates exercises

ACTIVE COMPARATOR

pilates exercise will be received three times a week for 10 weeks

Other: Pilates exercises

postural correction exercises

ACTIVE COMPARATOR

postural corrections exercise will be received three times a week for 10 weeks

Other: postural correction exercises

Interventions

ten exercises will be performed: 1. Hip Twist Level 1 2. Double leg stretch Level 1 3. Double leg stretch Level 2 4. One leg stretch Level 1 5. Clam Level 1 6. Scissors Level 1 7. Arm openings Level 1 8. Breast stroke prep Level 1t 9. Hip Twist Level 1. 10. Breast stroke prep Level 2 as for level 1 postural correction exercise 1-Strengthening deep cervical flexors 2-Stretching cervical extensors 3- Strengthen shoulder retractors 4-Unilateral and bilateral pectoralis stretch

Pilates and postural correction exercise

ten exercises will be performed: 1. Hip Twist Level 1 2. Double leg stretch Level 1 3. Double leg stretch Level 2 4. One leg stretch Level 1 5. Clam Level 1 6. Scissors Level 1 7. Arm openings Level 1 8. Breast stroke prep Level 1t 9. Hip Twist Level 1. 10. Breast stroke prep Level 2 as for level 1

Pilates exercises

postural correction exercise in the form of : 1. Strengthening deep cervical flexors through chin tucks, 2. Stretching cervical extensors through a chin drop 3. Strengthen shoulder retractors 4. Unilateral and bilateral pectoralis stretch alternating each two-week period.

postural correction exercises

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ages from 20-45 years old with symptomatic forward head posture will be included in this study
  • Participants have FHP if CVA ≤ 50 Non- athletes
  • Normal body mass index (BMI) (18- 24.9). (BMI = body mass in kg divided by subject height in meters).

You may not qualify if:

  • any spinal problems
  • Temporomandibular disease
  • Participants with experience in pilates and who will not be sedentary were excluded from the study
  • Previous surgery in the neck and shoulder
  • neurological symptoms of the upper extremities during screening tests (e.g., Spurling test and upper limb tension tests)
  • red flags suggesting of cancer, infection, vascular insufficiency
  • Cervical radiculopathy or mylopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Shaymaa Shaaban Abd El Azeim

Giza, 12511, Egypt

Location

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelop
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: this trial has three groups; one experimental and two groups control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 11, 2021

First Posted

December 28, 2021

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations