NCT04178369

Brief Summary

Limited ankle dorsiflexion adversely affects the weight bearing capacity, increases the knee extensor moment and causes insufficient maneuvers to change the center of gravity of the body in patients with hemiplegia. While biomechanical studies emphasized the importance of proximal tibiofibular joint and distal tibiofibular joint manipulations for ankle dorsiflexion, no studies examining the effect of corrective manipulation techniques applied to these two joints on foot posture, range of motion and balance were observed.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

November 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

December 20, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

November 25, 2019

Last Update Submit

November 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Foot Posture Index

    This index will be used to evaluate foot posture. During the assessment, all individuals will be asked to stand in the position where they fell the most comfortable. Six different parameters of the foot posture will be evaluated and scored between (-2) and (+2). These six parameters will be as follows: the palpation of talus head in hindfoot with the thumb and forefinger, the slope above and beneath the lateral malleolus, calcaneal supination and pronation, domination at the talonavicular joint area in the forefoot, the structure of medial longitudinal arc, and adduction and abduction of the forefoot compared to the hindfoot. The parameters scored as 0 will be considered as neutral position, while positive values represent pronation, and negative values express supination.

    6 weeks

Secondary Outcomes (2)

  • Range of Motion

    6 weeks

  • Berg Balance Scale

    6 weeks

Study Arms (2)

Experimental-Study Group

EXPERIMENTAL

In addition to the conservative treatment of the control group, proximal and distal tibiofibular joint manipulations will be applied for 6 weeks.

Other: Proximal And Distal Tibiofibular Joint Manipulations

Control Group

ACTIVE COMPARATOR

All participants were given a 6-week-long physiotherapy and rehabilitation program based on the Bobath concept (conservative treatment) for 5 days a week, 45 minutes each.

Other: Bobath Treatment

Interventions

For PTFJ, the experimental intervention will be based on previously published methods. Physiotherapist will make contact with the fibular head, extending to the popliteal fossa. The associated soft tissue will be pulled in a lateral direction until the metacarpophalangeal joint will be firmly stabilized behind the fibular head. For DTFJ, the experimental intervention will be conducted according to previously published methods. Physiotherapist will grasp and stabilize the distal tibia with one hand and grasp the distal fibula between the finger and thenar eminence of the other hand. The fibula will be translated posteriorly until the restrictive barrier (end range) will be engaged. Then a high-velocity, low-amplitude thrust will be applied through the fibula in a posterior-superior direction.

Experimental-Study Group

All participants will be given a 6-week-long physiotherapy and rehabilitation program based on the Bobath concept for 5 days a week, 45 minutes each. The techniques will be applied by a physiotherapist who is specialized in Bobath concept. 35 different techniques will be used to improve the selective control and weight transfer of the pelvis in sitting, standing and supine/side lying positions. Moreover, soft tissue mobilization will be also used to relieve tension and loosen stiff tissues to provide biomechanical alignment and reduce pain.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of chronic hemiplegia (˃6 months),
  • the ability to stand on the hemiplegic leg on a 30-cm-high step-board,
  • the ability to walk at least 10 m without any assistive device,
  • presence of limitation in ankle passive dorsiflexion (contracture),
  • the ability to understand and follow verbal commands,
  • to be volunteer to participate in the study.

You may not qualify if:

  • presence of any condition that is considered as a contraindication for mobilization (such as hypermobility, trauma, inflammation, etc.),
  • presence of any visual, verbal, or cognitive defects (such as aphasia, unilateral neglect, etc.),
  • having ankle sprain during the past 6 weeks,
  • patients who had undergone foot-ankle surgeries,
  • to receive any additional treatment within the time period of our study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • An CM, Won JI. Effects of ankle joint mobilization with movement and weight-bearing exercise on knee strength, ankle range of motion, and gait velocity in patients with stroke: a pilot study. J Phys Ther Sci. 2016 Jan;28(2):689-94. doi: 10.1589/jpts.28.689. Epub 2016 Feb 29.

  • An CM, Jo SO. Effects of Talocrural Mobilization with Movement on Ankle Strength, Mobility, and Weight-Bearing Ability in Hemiplegic Patients with Chronic Stroke: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2017 Jan;26(1):169-176. doi: 10.1016/j.jstrokecerebrovasdis.2016.09.005. Epub 2016 Oct 17.

  • Kluding PM, Santos M. Effects of ankle joint mobilizations in adults poststroke: a pilot study. Arch Phys Med Rehabil. 2008 Mar;89(3):449-56. doi: 10.1016/j.apmr.2007.12.005.

MeSH Terms

Conditions

HemiplegiaGait Disorders, NeurologicMobility Limitation

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Caner KARARTI, PT, MSc.

CONTACT

Çağdaş BASAT, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Caner Karartı, Hacettepe University

Study Record Dates

First Submitted

November 25, 2019

First Posted

November 26, 2019

Study Start

December 20, 2019

Primary Completion

March 20, 2020

Study Completion

April 20, 2020

Last Updated

November 26, 2019

Record last verified: 2019-11