Immediate Effect of Ankle Mobilization on Active Range of Motion and Gait in Subacute Stroke

Hemiparesis;Poststroke/CVA Clinical Trial

Official title:

Immediate Effect of Ankle Mobilization on Active Range of Motion and Gait in Subacute Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109194
• Other study ID #: 5230164
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Loma Linda University
• Contact: Eric G Johnson, PT, DSc
• Phone: 9095584632
• Email: ejohnson[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this observational study is to determine the effect of ankle joint mobilization on active range of motion and gait in subacute first-time stroke. The main questions it aims to answer are:

• What is the effect of ankle joint mobilization on active range of motion in the ankle and gait qualities?

• What is the effect of ankle joint mobilization on self-perceived gait ability?

Participants will receive physical therapy interventions of:

• Grade III ankle joint mobilization

• stretching of ankle plantarflexor muscles

• ankle muscle activation training

• assisted gait as part of assessment

Study design is to measure conditions before and after the intervention to determine effect(s) of one treatment dose, completed within one session of 90 minutes.

Description:

Initial passive and active ankle range of motion measured by goniometer. Initial gait quality will be measured by walking with splinting for frontal plane ankle stability if indicated, assistive device for body weight support if needed, and manual assistance from an experienced physical therapist, on a Zeno Walkway pressure-sensitive mat for five complete stride cycles, taking 3 to 5 minutes. Data collected from the mat will be electronically captured using ProtoKinetics software. Participant initial self-rated perception of ability to walk will be marked on a 0-10 scale, on paper. Treatment intervention follows. With participant lying on the back, paretic ankle moderate-force grade III anterior to posterior-directed manual joint mobilizations will be performed by therapist; three sets of fifteen oscillations. Ankle plantarflexor muscles will be stretched for 75 seconds in supported standing. Ankle dorsiflexion muscle activation training will be performed for three minutes while in a seated position. Post-intervention measurements will proceed in the same sequence as initial measurements listed above: Ankle passive and active range of motion and walking ability will be reassessed, and self-perceived ability to walk will be rated again.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 86 Years

Eligibility

Inclusion Criteria:

• First stroke

• subacute phase after stroke

• able to follow one-step commands

• paretic passive ankle dorsiflexion less than 5 degrees

Exclusion Criteria: referring to paretic ankle;

• ankle pain of undetermined cause at rest

• fracture in paretic lower extremity

• muscle or ligament tear

• recent ankle sprain

• skin tear or wound

• joint fusion or implanted hardware

Related Conditions & MeSH terms

• Hemiparesis;Poststroke/CVA
• Paresis

Intervention

Other:
• Joint mobilization
Grade III manual joint mobilization as standard-of-care physical therapy intervention

Locations

Country	Name	City	State
United States	Loma Linda University Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (12)

Alamer A, Melese H, Getie K, Deme S, Tsega M, Ayhualem S, Birhanie G, Abich Y, Yitayeh Gelaw A. Effect of Ankle Joint Mobilization with Movement on Range of Motion, Balance and Gait Function in Chronic Stroke Survivors: Systematic Review of Randomized Controlled Trials. Degener Neurol Neuromuscul Dis. 2021 Sep 1;11:51-60. doi: 10.2147/DNND.S317865. eCollection 2021. — View Citation

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. — View Citation

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. — View Citation

Cho KH, Park SJ. Effects of joint mobilization and stretching on the range of motion for ankle joint and spatiotemporal gait variables in stroke patients. J Stroke Cerebrovasc Dis. 2020 Aug;29(8):104933. doi: 10.1016/j.jstrokecerebrovasdis.2020.104933. Epub 2020 Jun 8. — View Citation

Forghany S, Nester CJ, Tyson SF, Preece S, Jones RK. The effect of stroke on foot kinematics and the functional consequences. Gait Posture. 2014 Apr;39(4):1051-6. doi: 10.1016/j.gaitpost.2014.01.006. Epub 2014 Jan 31. — View Citation

Forrester LW, Wheaton LA, Luft AR. Exercise-mediated locomotor recovery and lower-limb neuroplasticity after stroke. J Rehabil Res Dev. 2008;45(2):205-20. doi: 10.1682/jrrd.2007.02.0034. — View Citation

Gao F, Ren Y, Roth EJ, Harvey R, Zhang LQ. Effects of repeated ankle stretching on calf muscle-tendon and ankle biomechanical properties in stroke survivors. Clin Biomech (Bristol, Avon). 2011 Jun;26(5):516-22. doi: 10.1016/j.clinbiomech.2010.12.003. Epub 2011 Jan 6. — View Citation

Kang MH, Oh JS, Kwon OY, Weon JH, An DH, Yoo WG. Immediate combined effect of gastrocnemius stretching and sustained talocrural joint mobilization in individuals with limited ankle dorsiflexion: A randomized controlled trial. Man Ther. 2015 Dec;20(6):827-34. doi: 10.1016/j.math.2015.03.016. Epub 2015 Apr 2. — View Citation

Kim SL, Lee BH. The Effects of Posterior Talar Glide and Dorsiflexion of the Ankle Plus Mobilization with Movement on Balance and Gait Function in Patient with Chronic Stroke: A Randomized Controlled Trial. J Neurosci Rural Pract. 2018 Jan-Mar;9(1):61-67. doi: 10.4103/jnrp.jnrp_382_17. — View Citation

Mirbagheri MM, Alibiglou L, Thajchayapong M, Rymer WZ. Muscle and reflex changes with varying joint angle in hemiparetic stroke. J Neuroeng Rehabil. 2008 Feb 27;5:6. doi: 10.1186/1743-0003-5-6. — View Citation

Shorter AL, Richardson JK, Finucane SB, Joshi V, Gordon K, Rouse EJ. Characterization and clinical implications of ankle impedance during walking in chronic stroke. Sci Rep. 2021 Aug 18;11(1):16726. doi: 10.1038/s41598-021-95737-6. — View Citation

Simpson DB, Breslin M, Cumming T, de Zoete SA, Gall SL, Schmidt M, English C, Callisaya ML. Sedentary time and activity behaviors after stroke rehabilitation: Changes in the first 3 months home. Top Stroke Rehabil. 2021 Jan;28(1):42-51. doi: 10.1080/10749357.2020.1783917. Epub 2020 Jun 24. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active range of motion of the paretic ankle	ankle (talocrural) joint dorsiflexion movement of the foot away from plantarflexion end-range, measured by goniometry in seated position, by a physical therapist with 25 years' experience. Normal ankle ranges are 0 to 45 degrees from neutral for plantarflexion and 0-25 degrees from neutral for dorsiflexion. 0 to 15 degrees of dorsiflexion is needed for functionally efficient gait. Both passive and active ankle dorsiflexion range of motion are expected to increase, but be less than normal.	Change between baseline assessment and post-intervention assessment, immediately following intervention
Primary	Gait characteristic of: velocity	distance and time measurement captured as participant walks over a pressure-sensing mat. Data is processed with ProtoKinetics software. Velocity in meters per second is determined, and compared to normative values for non-stroke males (1.37 m/sec) and females (1.30 m/sec), and in relation to meaningful change in walking speed in in-patient stroke (0.13 m/sec). Velocity is anticipated to increase from pre- to post-intervention, but still be less than normal.	Change between baseline assessment and post-intervention assessment, immediately following intervention
Primary	Gait characteristic of: stride length	distance from foot contact to same foot contact measurement in meters captured as participant walks over a pressure-sensing mat. Data is processed with ProtoKinetics software. Findings will be compared to normative values for non-stroke males (1.51m) and females (1.32 m). Distance is hypothesized to increase post-intervention, but not approximate normal distance.	Change between baseline assessment and post-intervention assessment, immediately following intervention
Primary	Gait characteristic of: second double-limb stance time	Time measurement of the second occurrence when both feet are in contact with the ground, with reference to the paretic lower extremity. This will be compared to the normative value in adults of 0.12 second, and is hypothesized to be of lower duration post-intervention compared to pre-intervention, but still longer than normal.	Change between baseline assessment and post-intervention assessment, immediately following intervention
Primary	Gait characteristic of: stride length symmetry	distance from foot contact to same foot contact measurement in meters captured for each foot as participant walks over a pressure-sensing mat. Data is processed with ProtoKinetics software. Normal gait stride length is symmetrical for adults, and is hypothesized to improve from pre- to post-intervention measurement.	Change between baseline assessment and post-intervention assessment, immediately following intervention
Primary	Gait characteristic of: second double limb stance symmetry	Time measurement of the second occurrence when both feet are in contact with the ground. Times with reference to left and right lower extremity will be compared for symmetry. It is hypothesized that second double limb stance time will improve toward symmetry from pre- to post-intervention measurement.	Change between baseline assessment and post-intervention assessment, immediately following intervention
Secondary	Subjective rating of perceived ability to walk	Participant marks on paper self-perception of walking ability, responding to the instruction: 'please circle a point on the scale that shows level of confidence in walking a few steps unassisted on any household surface at this time. Where 0 = not at all confident and 10 = very confident'	Change between baseline assessment and post-intervention assessment, immediately following intervention