Hemiparesis;Poststroke/CVANCT06109194
Immediate Effect of Ankle Mobilization on Active Range of Motion and Gait in Subacute Stroke
A study testing Joint mobilization in people with Hemiparesis;Poststroke/CVA, run by Loma Linda University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 86 years
- Conditions the study is for
- Hemiparesis;Poststroke/CVA
- What is being tested?
- Joint mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2023to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First stroke
- subacute phase after stroke
- able to follow one-step commands
- paretic passive ankle dorsiflexion less than 5 degrees
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health
Loma Linda, California, 92350
About this study
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?
Read more
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.
Read the detailed 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.
- Conditions
- Hemiparesis;Poststroke/CVA
- Being tested
- Joint mobilization
- Keywords
- subacute stroke, gait, dorsiflexion, joint mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint mobilizationOther
Also called manual therapy, tissue stretch
Grade III manual joint mobilization as standard-of-care physical therapy intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Pre-assessment of active and passive range of motion in the paretic ankle, and five strides of gait assessment on a pressure-sensitive mat. Intervention will be moderate grade III anterior-to-posterior directed ankle mobilization for 2 minutes while supine, ankle muscle stretch for 75 seconds in standing, ankle muscle training for 3 minutes while seated. Post-assessment is repeated in the same sequence and content as pre-assessment. Receives: Other: Joint mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline assessment and post-intervention assessment, immediately following intervention
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.
Measured: Change between baseline assessment and post-intervention assessment, immediately following intervention
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.
Measured: Change between baseline assessment and post-intervention assessment, immediately following intervention
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.
Measured: Change between baseline assessment and post-intervention assessment, immediately following intervention
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.
Measured: Change between baseline assessment and post-intervention assessment, immediately following intervention
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.
Measured: Change between baseline assessment and post-intervention assessment, immediately following intervention
Secondary outcomes (1)
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'
Measured: Change between baseline assessment and post-intervention assessment, immediately following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start19 Dec 2023
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hemiparesis;Poststroke/CVAStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre-test, intervention, post-test
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric G Johnson, PT, DSc, Study chair, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109194
- Sponsor's protocol ID
- 5230164
- Status last verified
- Jan 2025
- First submitted
- 25 Oct 2023
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29456346An 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.
PubMed 27765557An 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.
PubMed 27065565Alamer 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.
PubMed 34512072Cho 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.
PubMed 32689617Kang 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.
PubMed 25907146Gao 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). 2011 Jun;26(5):516-22. doi: 10.1016/j.clinbiomech.2010.12.003. Epub 2011 Jan 6.
PubMed 21211873Forghany 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.
PubMed 24548798Mirbagheri 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.
PubMed 18304313Shorter 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.
PubMed 34408174Forrester 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.
PubMed 18566939Simpson 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.
PubMed 32578523
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Ankle Mobilization on Active Range of Motion and Gait in Subacute Stroke
- ClinicalTrials.gov ID
- NCT06109194
- Acronym / sponsor ID
- 5230164
- Conditions
- Hemiparesis;Poststroke/CVA
- Keywords
- subacute stroke, gait, dorsiflexion, joint mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre-test, intervention, post-test
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Joint mobilizationPre-assessment of active and passive range of motion in the paretic ankle, and five strides of gait assessment on a pressure-sensitive mat. Intervention will be moderate grade III anterior-to-posterior directed ankle mobilization for 2 minutes while supine, ankle muscle stretch for 75 seconds in standing, ankle muscle training for 3 minutes while seated. Post-assessment is repeated in the same sequence and content as pre-assessment. |
Who may qualify
- Ages
- 21 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First stroke
- subacute phase after stroke
- able to follow one-step commands
- paretic passive ankle dorsiflexion less than 5 degrees
Key exclusion criteria (6 listed)
- ankle pain of undetermined cause at rest
- fracture in paretic lower extremity
- muscle or ligament tear
- recent ankle sprain
- skin tear or wound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint mobilizationAlso: manual therapy, tissue stretchGrade III manual joint mobilization as standard-of-care physical therapy intervention | Other | Intervention |
Primary outcome
Active range of motion of the paretic ankle
Time frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
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.
Gait characteristic of: velocity
Time frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
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.
Gait characteristic of: stride length
Time frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
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.
Gait characteristic of: second double-limb stance time
Time frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
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.
Gait characteristic of: stride length symmetry
Time frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
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.
Gait characteristic of: second double limb stance symmetry
Time frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
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.
1 secondary outcome
Subjective rating of perceived ability to walk
Time frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Background: PubMed 29456346Kim 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.
- Background: PubMed 27765557An 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.
- Background: PubMed 27065565An 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.
- Background: PubMed 34512072Alamer 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.
- Background: PubMed 32689617Cho 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.
- Background: PubMed 25907146Kang 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.
- Background: PubMed 21211873Gao 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). 2011 Jun;26(5):516-22. doi: 10.1016/j.clinbiomech.2010.12.003. Epub 2011 Jan 6.
- Background: PubMed 24548798Forghany 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.
- Background: PubMed 18304313Mirbagheri 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.
- Background: PubMed 34408174Shorter 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.
- Background: PubMed 18566939Forrester 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.
- Background: PubMed 32578523Simpson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric G Johnson, PT, DSc study chair
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint mobilization in people with Hemiparesis;Poststroke/CVA, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active range of motion of the paretic ankle (time frame: Change between baseline assessment and post-intervention assessment, immediately following intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06109194, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.