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Effect of Foot Muscles Training and Foot Orthosis on the Medial Arch in Flatfoot Subjects

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ClinicalTrials.gov Identifier: NCT04480177
Recruitment Status : Completed
First Posted : July 21, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Shaikha Uthman, Imam Abdulrahman Bin Faisal University

Brief Summary:

Orthotic therapy or exercise therapy is the standard conservative treatment for flexible flat foot. Little is known about the effectiveness of their interaction on managing flatfoot.

The study aims to evaluate the effect of insoles and short foot exercise on the height and area of the medial longitudinal arch of flexible flatfoot participants as well as the force and pressure.


Condition or disease Intervention/treatment Phase
Flexible Flatfoot Device: foot insole Other: short foot exercise Not Applicable

Detailed Description:

Study design: A parallel, active-control study design was used to conduct a single-blinded randomized controlled trial.

Method: The toe rising test, the "too many toes" sign, and the navicular drop test was used to select 30 participants with flexible flatfoot. Participants was randomly assigned either to an experimental group (n = 15) or a control group (n = 15). The experimental group received short foot exercises (SFE) and insoles, and the control group received only insoles. SFE was implemented 30 times for a duration of three minutes each day over the course of six weeks. The exercise progressed from sitting to standing and finally to one leg stance position within every two weeks. The participants wore shoes containing orthotic insoles for eight hours per day for six weeks. The EMED-x system was used to measure plantar pressure distribution (force, area, and pressure) at baseline and at two-week intervals throughout the six-week intervention. The Lower Extremity Functional Scale (LEFS) was used to evaluate restriction in participants' functional abilities, and the navicular drop test (NDT) was used to assess the medial longitudinal arch (MLA) height. Both variables were measured at baseline and at the sixth week.

Statistics: Mixed-effects ANOVA was used to test for significant interactions between the two groups across time and within-subject observations of the outcomes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Intrinsic Foot Muscles Training and Foot Orthosis on the Medial Longitudinal Arch in Flexible Flatfoot Subjects
Actual Study Start Date : October 27, 2018
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
insole group
the control group receives insole only.
Device: foot insole
the subject was instructed to wear foot insole for 8 hours.

Experimental: exercise group
the experimental group receives exercise and insole.
Device: foot insole
the subject was instructed to wear foot insole for 8 hours.

Other: short foot exercise
the subject was instructed to perform exercise once a day 30 repetitions.




Primary Outcome Measures :
  1. The EMED (force-area-pressure) [ Time Frame: 6 weeks ]
    The feet plantar pressure was measured at baseline and at two-week intervals throughout the six-week intervention.


Secondary Outcome Measures :
  1. Lower extremities functional scale, navicular drop test [ Time Frame: 6 weeks ]
    The Lower extremities functional scale was used to evaluate restriction in participants' functional abilities, The score ranges from 0 to 80, and if it is higher indicating less functional restrictions. The navicular drop test was used to assess the medial longitudinal arch (MLA) height, A positive result for the navicular drop test is an arch height more than or equal to 10 mm. Both variables were measured at baseline and at the sixth week.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females and males aged between 18 and 36
  • Bilateral symptomatic flexible flatfoot, with symptoms including foot pain and lower limb fatigue
  • Participants must show positive physical examination findings, including a positive result for the "too many toes" sign, the navicular drop test, and the foot toe raising test (Carr et al., 2016). A positive result for the "too many toes" sign occurs when more toes can be seen on the lateral side of each foot due to external rotation and abduction of the feet, and the positive result for the toe rising test is the reconstruction of the medial longitudinal arch secondary to the tightness of the plantar fascia (Carr et al., 2016). A positive result for the navicular drop test is an arch height more than or equal to 10 mm(Aenumulapalli et al., 2017)

Exclusion Criteria:

  • An anatomical discrepancy in leg length
  • Pathologic or neurologic disorders of the feet
  • A history of traumatic foot injury or surgery within the last six months
  • History of wearing foot orthoses within the past two years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480177


Locations
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Saudi Arabia
Imam Abdulrahman Bin Faisal University
Dammam, Eastren, Saudi Arabia
Sponsors and Collaborators
Imam Abdulrahman Bin Faisal University
Publications:
Abdel-Fattah, M.M., Hassanin, M.M., Felembane, F.A., Nassaane, M.T., 2006. Flat foot among Saudi Arabian army recruits: prevalence and risk factors. East. Mediterr. Health J. Rev. Sante Mediterr. Orient. Al-Majallah Al-Sihhiyah Li-Sharq Al-Mutawassit 12, 211-217. Abousayed, M.M., Tartaglione, J.P., Rosenbaum, A.J., Dipreta, J.A., 2016. Classifications in Brief: Johnson and Strom Classification of Adult-acquired Flatfoot Deformity. Clin. Orthop. 474, 588-593. Aenumulapalli, A., Kulkarni, M.M., Gandotra, A.R., 2017. Prevalence of Flexible Flat Foot in Adults: A Cross-sectional Study. J. Clin. Diagn. Res. JCDR 11, AC17-AC20. Allen, M.K., Glasoe, W.M., 2000. Metrecom Measurement of Navicular Drop in Subjects with Anterior Cruciate Ligament Injury. J. Athl. Train. 35, 403-406. Alnahdi, A.H., Alrashid, G.I., Alkhaldi, H.A., Aldali, A.Z., 2016. Cross-cultural adaptation, validity and reliability of the Arabic version of the Lower Extremity Functional Scale. Disabil. Rehabil. 38, 897-904. Aminian, G., Safaeepour, Z., Farhoodi, M., Pezeshk, A.F., Saeedi, H., Majddoleslam, B., 2013. The effect of prefabricated and proprioceptive foot orthoses on plantar pressure distribution in patients with flexible flatfoot during walking. Prosthet. Orthot. Int. 37, 227-232. Banwell, H.A., Mackintosh, S., Thewlis, D., 2014. Foot orthoses for adults with flexible pes planus: a systematic review. J. Foot Ankle Res. 7, 23. Buldt, A.K., Forghany, S., Landorf, K.B., Levinger, P., Murley, G.S., Menz, H.B., 2018. Foot posture is associated with plantar pressure during gait: A comparison of normal, planus and cavus feet. Gait Posture 62, 235-240. https://doi.org/10.1016/j.gaitpost.2018.03.005 Carr, J.B., Yang, S., Lather, L.A., 2016. Pediatric Pes Planus: A State-of-the-Art Review. Pediatrics 137, e20151230. Chen, Y.-C., Lou, S.-Z., Huang, C.-Y., Su, F.-C., 2010. Effects of foot orthoses on gait patterns of flat feet patients. Clin. Biomech. Bristol Avon 25, 265-270. Cheng, Y., Yang, H., Ni, L., Song, D., Zhang, H., 2015. Stress fracture of the distal fibula in flatfoot patients: case report. Int. J. Clin. Exp. Med. 8, 6303-6307. Chuter, V., Spink, M., Searle, A., Ho, A., 2014. The effectiveness of shoe insoles for the prevention and treatment of low back pain: a systematic review and meta-analysis of randomised controlled trials. BMC Musculoskelet. Disord. 15, 140. https://doi.org/10.1186/1471-2474-15-140 Daniels, T.R., Lau, J.T., Hearn, T.C., 1998. The effects of foot position and load on tibial nerve tension. Foot Ankle Int. 19, 73-78. https://doi.org/10.1177/107110079801900204 Dars, S., Uden, H., Kumar, S., Banwell, H.A., 2018. When, why and how foot orthoses (FOs) should be prescribed for children with flexible pes planus: a Delphi survey of podiatrists. PeerJ 6, e4667. https://doi.org/10.7717/peerj.4667 Giacomozzi, C., 2010. Appropriateness of plantar pressure measurement devices: A comparative technical assessment. Gait Posture 32, 141-144. https://doi.org/10.1016/j.gaitpost.2010.03.014 Hafer, J.F., Lenhoff, M.W., Song, J., Jordan, J.M., Hannan, M.T., Hillstrom, H.J., 2013. Reliability of plantar pressure platforms. Gait Posture 38, 544-548. https://doi.org/10.1016/j.gaitpost.2013.01.028 Hatfield, G.L., Cochrane, C.K., Takacs, J., Krowchuk, N.M., Chang, R., Hinman, R.S., Hunt, M.A., 2016. Knee and ankle biomechanics with lateral wedges with and without a custom arch support in those with medial knee osteoarthritis and flat feet. J. Orthop. Res. Off. Publ. Orthop. Res. Soc. 34, 1597-1605. https://doi.org/10.1002/jor.23174 Hegedus, E.J., Cook, C., Fiander, C., Wright, A., 2010. Measures of arch height and their relationship to pain and dysfunction in people with lower limb impairments. Physiother. Res. Int. 15, 160-166. https://doi.org/10.1002/pri.459 Hsieh, R.-L., Peng, H.-L., Lee, W.-C., 2018. Short-term effects of customized arch support insoles on symptomatic flexible flatfoot in children: A randomized controlled trial. Medicine (Baltimore) 97, e10655. https://doi.org/10.1097/MD.0000000000010655 Huang, Y.-C., Wang, L.-Y., Wang, H.-C., Chang, K.-L., Leong, C.-P., 2004. The relationship between the flexible flatfoot and plantar fasciitis: ultrasonographic evaluation. Chang Gung Med. J. 27, 443-448. Imhauser, C.W., Abidi, N.A., Frankel, D.Z., Gavin, K., Siegler, S., 2002. Biomechanical evaluation of the efficacy of external stabilizers in the conservative treatment of acquired flatfoot deformity. Foot Ankle Int. 23, 727-737.

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Responsible Party: Shaikha Uthman, master student, Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier: NCT04480177    
Other Study ID Numbers: PGS-2018-03-184
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shaikha Uthman, Imam Abdulrahman Bin Faisal University:
Flatfoot
Insole
Short-foot exercise
Orthotic
Additional relevant MeSH terms:
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Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities