Use of Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait

Chronic Stroke Clinical Trial

Official title:

Investigation of the Effect of Using Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394635
• Other study ID #: 349c6c25d7a64a22
• Status: Recruiting
• Start date: March 22, 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Hacettepe University
• Contact: Büsra Seçkinogullari Korkusuz, MSc
• Phone: 05442436914
• Email: busrasec[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hypothesis 1:

Ho: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on knee hyperextension control in stroke patients with genurecurvatum gait.

H1: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on knee hyperextension control in stroke patients with genurecurvatum gait.

Hypothesis 2:

Ho: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on pelvic movements in stroke patients with genurecurvatum gait.

H1: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on pelvic movements in stroke patients with genurecurvatum gait.

Description:

Kinematic evaluation of the gaits of stroke patients in 3 different situations will be made in the motion analysis system. Patients will be asked to walk at a normal walking pace for a distance of only 5 meters. Patients will walk the 5-meter distance first without the Ankle-Foot Orthosis, then with the Ankle-Foot Orthosis adjusted at 3 degrees of dorsiflexion, and then with the Ankle-Foot Orthosis adjusted at 5 degrees of dorsiflexion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• At least 6 months have passed since the stroke incident

• Ambulating with or without a walking aid (walker, cane or tripod)

• Being between 0-3 points according to the Modified Rankin Scoring

• Getting a score of 24 or above from the Mini Mental Test

• Presence of hyperextension in the stance phase of gait

• Volunteering to participate in the study

Exclusion Criteria:

• Having a history of more than one stroke

• Known presence of dementia

• Having a known orthopedic, psychiatric or other neurological disease

• There is a situation that prevents communication

• Having a history of surgery involving the lower extremities and gait

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bae DY, Shin JH, Kim JS. Effects of dorsiflexor functional electrical stimulation compared to an ankle/foot orthosis on stroke-related genu recurvatum gait. J Phys Ther Sci. 2019 Nov;31(11):865-868. doi: 10.1589/jpts.31.865. Epub 2019 Nov 26. — View Citation

Geerars M, Minnaar-van der Feen N, Huisstede BMA. Treatment of knee hyperextension in post-stroke gait. A systematic review. Gait Posture. 2022 Jan;91:137-148. doi: 10.1016/j.gaitpost.2021.08.016. Epub 2021 Aug 24. — View Citation

Kobayashi T, Orendurff MS, Singer ML, Gao F, Daly WK, Foreman KB. Reduction of genu recurvatum through adjustment of plantarflexion resistance of an articulated ankle-foot orthosis in individuals post-stroke. Clin Biomech (Bristol, Avon). 2016 Jun;35:81-5. doi: 10.1016/j.clinbiomech.2016.04.011. Epub 2016 Apr 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement Analysis	Reflective signs will be placed on certain anatomical points on the participants and the participants will be asked to walk at a distance of 5 meters. The three-dimensional positions of these reflective signs will be captured with the 8-camera Vicon motion capture system and recorded on the computer using Blade software.	Baseline