NCT06086600

Brief Summary

Rationale of this research is to compare the effect of instrument assisted soft tissue mobilization and dynamic oscillatory stretch technique on gastro soleus muscles flexibility with shortened calf muscle-tendon unit (MTU),thicker and stiffer Achilles tendon in individual wearing high heel. This study will observe effect in all range of motion of ankle joint. In Pakistan no previous research is conducted, that compare the effect of IASTM and DOST in females wearing high heel.

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
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

October 11, 2023

Last Update Submit

October 11, 2023

Conditions

Behavior, Social

Keywords

instrument assisted soft tissue mobilizationdynamic oscillatory stretch techniquehigh heel users

Outcome Measures

Primary Outcomes (3)

  • Ankle Range of Motion

    Goniometer is used to measure ankle dorsiflexion, Plantarflexion, inversion, eversion ROM and it is use to assess and monitor patient's mobility to track progress during rehabilitation.

    4th week

  • Lower Extremity Functional Scale (LEFS)

    The Lower Extremity Functional Scale (LEFS) is a commonly used tool in physical therapy and rehabilitation to assess the functional abilities of patients with lower extremity impairments. It is a self-reported questionnaire that consists of 20 items, each with five response options ranging from 0 (unable to perform) to 4 (able to perform without difficulty). The scores on the LEFS range from 0 to 80, with higher scores indicating better function.

    4th week

  • NUMERIC PAIN RATING SCALE

    The numeric pain rating scale is used to measure pain intensity. It typically ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. Patients are asked to rate their pain on this scale, with the healthcare provider using the rating to help guide treatment decisions. It is a simple and effective way to communicate pain intensity, and can be useful in tracking changes in pain over time.

    4th week

Secondary Outcomes (4)

  • ROM ankle dorsi flexion

    4th week

  • ROM ankle plantar flexion

    4th week

  • ROM ankle inversion

    4th week

  • ROM ankle eversion

    4th week

Study Arms (2)

Instrument Assisted Soft Tissue Mobilization

EXPERIMENTAL

Graston tool on gastrocnemius and soleus muscle. Conventional treatment will include * Hot pack for 10-15 min (calf muscles) * Stretching exercises of gastro-soleus (10reps x 2Sets). * Post session : Cold pack for 5 minutes (calf muscles)

Other: Instrument Assisted Soft Tissue Mobilization

Dynamic oscillatory stretch technique

ACTIVE COMPARATOR

Dynamic oscillatory stretch technique on gastrocnemius and soleus muscle10reps x2 second hold oscillation x 3 sets. Conventional treatment will include * Hot pack for 10-15 min (calf muscles) * Stretching exercises of gastro-soleus (10reps x 2 Sets). * Post session : Cold pack for 5 minutes (calf Muscles

Other: Dynamic oscillatory stretch technique

Interventions

Instrument Assisted Soft Tissue MobilizationOTHER

give gentle strokes from proximal to distal to check for trigger point or taut band. After knowing the exact location, give gentle strokes with minimal pressure in all directions by keeping the instrument in 30 to 60 degree angle. Application time will be between 40- 120 seconds. Conventional treatment will include * Hot pack for 10-15 min (calf muscles) * Stretching exercises of gastro-soleus (10reps x 2Sets). * Post session : Cold pack for 5 minutes (calf muscles)

Instrument Assisted Soft Tissue Mobilization
Dynamic oscillatory stretch techniqueOTHER

Passively dorsiflexe the ankle to a point of the first stretch sensation. The next component to DOS, 2- second, passive stretch with slow oscillations at end range was applied. This procedure is repeated 10 times in each set with total of 3 sets .Therefore,10reps x2 second hold oscillation x 3 sets are given.Conventional treatment will include * Hot pack for 10-15 min (calf muscles) * Stretching exercises of gastro-soleus (10reps x 2Sets). * Post session : Cold pack for 5 minutes (calf muscles

Dynamic oscillatory stretch technique

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-40 years
  • Duration of wearing heels: minimum 1 year
  • Wearing heels for minimum 3 times a week and 5 hours a day.
  • Heel height: 2" and above
  • Ankle Dorsiflexion ROM: decreased dorsiflexion (about 17 degrees)
  • Pain scale showing more than 3.

You may not qualify if:

  • DVT
  • Musculoskeletal injury or surgery of lower limb.
  • Acute Cardio-Respiratory or Neurological condition.
  • Medical or surgical co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulberg green campus of Riphah International University

Islamabad, Punjab Province, 44000, Pakistan

RECRUITING

Related Publications (2)

  • Chien HL, Lu TW, Liu MW. Effects of long-term wearing of high-heeled shoes on the control of the body's center of mass motion in relation to the center of pressure during walking. Gait Posture. 2014 Apr;39(4):1045-50. doi: 10.1016/j.gaitpost.2014.01.007. Epub 2014 Jan 19.

    PMID: 24508016BACKGROUND

  • Pannell SL. The postural and biomechanical effects of high heel shoes: a literature review. Journal of Vascular Surgery. 2012.

    BACKGROUND

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ramsha Tariq, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramsha Tariq, MS-OMPT

CONTACT

03315251422ramsha.tariq@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

April 10, 2023

Primary Completion

January 15, 2024

Study Completion

January 15, 2024

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)