THE STUDY COMPARING THE EFFECTIVENESS OF EXERCISES ALONG WITH MAITLAND NAVICULAR MOBILIZATION VERSUS EXERCISES ALONE IN PATIENTS WITH PES PLANUS: A RANDOMIZED CONTROL TRAIL
The purpose of this study was to find the comparative impact of exercises with navicular mobilization versus exercise alone in patients with flat foot. In flat foot, hence the foot is pronated so the mobilization has to be given in order to improve normal biomechanics of foot or to elevate the medial arch. There is paucity of literature on mid foot mobilization in patients having flat foot. So, a comparative effect of these treatments on the navicular height and foot posture index in patients with flat foot was done to find out which one was superior to the other.
Design
Two arm parallel group randomised trial
Settings and conduct
Rehman Medical Institute, Peshawar
However, assessor, who will assess pre and post measurements, will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Subjects aged between 18 to 30 years
2. Both males and females
3. Unilateral or bilateral involvement
4. Subjects having flexible flat feet with navicular drop test positive
Exclusion Criteria:
1.History of fractures in the lower limb
2. Skin infections and wounds on the foot
4. Any neurological deficit
5. Peripheral vascular diseases.
Intervention groups
Control Group (Group A): Resistive exercises using TheraBand of 12 repetitions and 3 sets. Resistive exercises will contain plantarflexion, inversion, flexion of big toe and abduction of big toe
Experimental Group (Group B): Group B will be given talonavicular mobilization along with exercises. In talonavicular mobilization, a dorsal glide of 3 sets and 20 repetitions will be given to the navicular while stabilizing the talar neck. Resistive exercises using TheraBand will be given with 12 repetitions of 3 sets.
Main outcome variables
Outcome measures will be used on baseline, 1st assessment (after 3 weeks) and 2nd assessment (after 6 weeks) using Foot Posture Index (FPI) and navicular drop test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220523054969N1
Registration date:2022-05-24, 1401/03/03
Registration timing:prospective
Last update:2022-05-24, 1401/03/03
Update count:0
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Aqsa Wisal
Name of organization / entity
Rehman medical institute, Peshawar
Country
Pakistan
Phone
+92 91 5838000
Email address
aqsa.wisal@rmi.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-23, 1401/04/02
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
THE STUDY COMPARING THE EFFECTIVENESS OF EXERCISES ALONG WITH MAITLAND NAVICULAR MOBILIZATION VERSUS EXERCISES ALONE IN PATIENTS WITH PES PLANUS: A RANDOMIZED CONTROL TRAIL
Public title
THE STUDY COMPARING THE EFFECTIVENESS OF EXERCISES ALONG WITH MAITLAND NAVICULAR MOBILIZATION VERSUS EXERCISES ALONE IN PATIENTS WITH PES PLANUS: A RANDOMIZED CONTROL TRAIL
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects aged between 18 to 30 years
Both males and females
Unilateral or bilateral involvement
Subjects having flexible flat feet with navicular drop test positive.
Exclusion criteria:
History of fractures in the lower limb
Skin infections and wounds on the foo
Any neurological deficit
Peripheral vascular diseases.
Age
From 18 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelopes
After participants are selected, they will be randomly allocated to control group and experimental group using lottery method in which they will be asked to select a piece of paper from a box. The piece of paper will be marked with initial of the groups (such as A or B) and then the participants will be allocated to the group initial that was on paper.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to nature of study, it will not be feasible to blind researcher/therapist and subjects. However, assessor, who will assess pre and post measurements, will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AS&RB
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad
City
PESHAWAR
Postal code
25100
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
Not issued yet
Health conditions studied
1
Description of health condition studied
Flat Foot
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Navicular Height
Timepoint
Outcome measures will be used on baseline, 1st assessment (after 3 weeks) and 2nd assessment (after 6 weeks)
Method of measurement
Navicular drop test
Secondary outcomes
1
Description
Flat Foot
Timepoint
Outcome measures will be used on baseline, 1st assessment (after 3 weeks) and 2nd assessment (after 6 weeks)
Method of measurement
Foot posture index
Intervention groups
1
Description
Intervention group: talonavicular mobilization along with exercises. In talonavicular mobilization, a dorsal glide of 3 sets and 20 repetitions will be given to the navicular while stabilizing the talar neck. Resistive exercises using TheraBand will be given with 12 repetitions of 3 sets. Resistive exercises will contain plantarflexion, inversion, flexion of big toe and abduction of big toe.
Category
Rehabilitation
2
Description
Control group: Resistive exercises using TheraBand of 12 repetitions and 3 sets. Resistive exercises will contain plantarflexion, inversion, flexion of big toe and abduction of big toe will be given
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehman Medical Institute, Peshawar
Full name of responsible person
Aqsa Wisal
Street address
5/B-2 Phase 5
City
PESHAWAR
Postal code
25000
Phone
+92 91 5838000
Email
aqsa.wisal@rmi.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khyber Medical Institute, Peshawar
Full name of responsible person
Rida Shabbir
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad
City
Peshawar
Postal code
25000
Phone
+92 91 5892885
Email
ipmr@kmu.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?