StrokeNCT06840132
The Effect of Ankle Foot Orthesis on Task-oriented Treatment in Stroke
A study testing Exercise in people with Stroke, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
A stroke is a neurological condition and a major cause of disability in adults. It occurs suddenly and causes specific brain function problems, leading to noticeable symptoms that last for more than 24 hours.Stroke commonly causes impairments in sensory, motor, and cognitive functions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2020to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and older,
- Who had experienced their first stroke,
- Brunnstrom lower extremity score of ≥3,
- Functional Ambulation Classification score of ≥2,
- At least 3 months post-stroke,
- Having no other neurological disorders
Who cannot join
- Under 18 age,
- Having an another neurologic disorder
Trial locations and contacts
1 site in 1 country.
About this study
A stroke is a neurological condition and a major cause of disability in adults. It occurs suddenly and causes specific brain function problems, leading to noticeable symptoms that last for more than 24 hours.Stroke commonly causes impairments in sensory, motor, and cognitive functions. Approximately 80% of patients experience motor deficits in the lower extremities, often accompanied by balance disturbance (3). Traditionally, neurodevelopmental treatments aimed at restoring normal movement patterns have been used in stroke rehabilitation. However, research on both animals and humans has shown that this approach alone is insufficient. These studies have shown that task-oriented functional exercise training can induce changes in activation patterns in a large portion of the damaged brain areas, leading to restoration of function (4, 5). Engaging in meaningful and repetitive goal-directed functional tasks can effectively enhance neuroplasticity and facilitate recovery.
Task-oriented training is an exercise therapy designed for stroke patients, based on motor learning theory, which emphasizes the repetition of motor skills and aims to enhance performance through meaningful tasks . Lord et al. were the first researchers to conceptually apply task-oriented training, using a total of 19 different functional exercises in their study. They found that both deficiency-based and task-oriented training showed similar results in terms of improving walking and balance skills. However, more recent studies have shown that task-specific, task-oriented treatment programs are superior to traditional facilitation-based therapeutic approaches. Another study comparing conventional physiotherapy, task-oriented group training, and individual task-oriented training, with the aim of assessing the effects of exercises, demonstrated that task-oriented group training led to better outcomes in tasks such as sitting, standing, overcoming obstacles, circular walking, and carrying objects.
Read more
Two others found that the foot was more dorsiflexed at higher stiffnesses during initial contact in patients post- stroke An Ankle-Foot Orthosis (AFO) plays a crucial role in individuals with paralysis during walking, particularly in the heel strike and loading phases, by restraining plantar flexion and assisting the impaired function of the dorsiflexors. In individuals with paralysis, dorsiflexion, the upward movement of the ankle, is often weakened or lost. The AFO helps address this issue by maintaining the desired position of the ankle joint, contributing to the preservation of normal gait during walking.
Additionally, during the swing phase (when the leg moves forward), the AFO helps maintain the ankle joint position, supporting toe-off. This enhances walking efficiency and provides stability during the step. Thus, the AFO not only offers support but also significantly contributes to functional improvement, greatly enhancing the walking ability of individuals with paralysis.
Combined use of task-oriented training and orthoses are typically focused on the upper extremity functions rather than the lower extremity functions in patients with stroke. Therefore, in this study, it was aimed to investigate the effects of task-oriented training with and without an ankle-foot orthosis (AFO) on lower extremity function in individuals with stroke. It was hypothesized that task-oriented training with an AFO would lead to greater improvements in lower extremity function such as balance, walking, and stability and quality of life in stroke patients.
The study included 40 individuals with stroke. The inclusion criteria of the study were as follows: aged 18 and older, who had experienced their first stroke, Brunnstrom lower extremity score of ≥3, a Functional Ambulation Classification score of ≥2, at least 3 months post-stroke, and having no other neurological disorders. The individuals will be diagnosed at the Physical Therapy and Rehabilitation outpatient clinic of Balıkesir Atatürk City Hospital by the same neurologist and received treatment at the hospital's rehabilitation department.All patients participated in an intensive physical therapy program for 1 hour per day, 5 days a week, over a period of 4 weeks. For GoPT, a 7-station exercise protocol designed, consisting of motor activities progressing from easy to difficult, with the goal of transforming these activities into permanent skills through meaningful tasks. Participants randomly divided into two groups: the task-oriented physical therapy group (GoPT) (n=19), the task-oriented program plus plastic static ankle-foot orthosis group (GoPT+AFO) (n=20). All participants in the groups were evaluated by a physiotherapist before treatment and after the 4-week intervention period.Six-Minute Walk Test, 10-Meter Walk Test,Timed Up and Go Test,Berg Balance Scale, Functional Reach Test,Stroke Impact Scale were evaluated.
Read the detailed description
Before starting the study, an application was made to Balıkesir University Non-Interventional Clinical Research Ethics Committee. Usage started with the permission of the ethics committee, decision dated 13.12.2017 and 2017/156.
- Conditions
- Stroke
- Being tested
- Exercise
- Keywords
- stroke, foot orthoses, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
Also called task oriented exercise therapy
7-station exercise protocol was designed, consisting of motor activities progressing from easy to difficult, with the goal of transforming these activities into permanent skills through meaningful tasks. Each station aimed to gradually improve the patient's motor abilities. Patients were allowed to rest between tasks, and the difficulty of the tasks progressively increased based on each patient's capacity. This 7-station protocol was designed for the first time by our own research team
ExerciseProcedure or surgery
Also called task oriented training + orthoses
In addition to the task-oriented training program, the group using plastic static ankle-foot orthoses performed the same 7-station exercise protocol as the task oriented training group. However, participants in this group were required to wear custom-made plastic static ankle-foot orthoses while completing the exercises.
| Study group | Role | What they receive |
|---|---|---|
| the task-oriented training | Active comparator | patients participated in an intensive physical therapy program for 1 hour per day, 5 days a week, over a period of 4 weeks. For GoPT, a 7-station exercise protocol was designed, consisting of motor activities progressing from easy to difficult, with the goal of transforming these activities into permanent skills through meaningful tasks. Each station aimed to gradually improve the patient's motor abilities. Patients were allowed to rest between tasks, and the difficulty of the tasks progressively increased based on each patient's capacity. This 7-station protocol was designed for the first time by our own research team, and the details of the GoPT program Receives: Procedure: Exercise |
| the task-oriented training plus plastic static ankle-foot orthosis group | Active comparator | patients participated in an intensive physical therapy program for 1 hour per day, 5 days a week, over a period of 4 weeks. group using plastic static ankle-foot orthoses (GoPT+AFO) performed the same 7-station exercise protocol as the GoPT group. However, participants in this group were required to wear custom-made plastic static ankle-foot orthoses while completing the exercises. Both the patients and their families were educated on the proper use of the orthosis and encouraged to wear it in daily life as well. Receives: Procedure: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
six meter walk
endurance test. It is assessed by having the person walk continuously for 6 minutes at the maximum speed they can walk in a 30-meter area. The distance walked during this time is recorded. Increased walking distance is perceived positively
Measured: from enrollement to the end of four weeks
Secondary outcomes (1)
berg balance scale
balance evaluation. Each activity is given a score between 0-4. The best score is 56. 0-20 is interpreted as poor balance, 21-40 as acceptable balance, and 41-56 as advanced balance skills.
Measured: from enrollement to the end of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start2 Feb 2020
- Primary completion1 May 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Balikesir Ataturk City Hospital
- Responsible party
- Principal investigator, Sezen Dincer, Ankara Medipol University
- Investigators
- sezen dincer, asst prof, Principal investigator, ankara medipol univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840132
- Sponsor's protocol ID
- Balıkesir Atatürk CityHospital
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song HS, Kim JY, Park SD. The effect of class-based task-oriented circuit training on the self-satisfaction of patients with chronic stroke. J Phys Ther Sci. 2015 Jan;27(1):127-9. doi: 10.1589/jpts.27.127. Epub 2015 Jan 9.
PubMed 25642055French B, Thomas LH, Coupe J, McMahon NE, Connell L, Harrison J, Sutton CJ, Tishkovskaya S, Watkins CL. Repetitive task training for improving functional ability after stroke. Cochrane Database Syst Rev. 2016 Nov 14;11(11):CD006073. doi: 10.1002/14651858.CD006073.pub3.
PubMed 27841442Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.
PubMed 33501848
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ankle Foot Orthesis on Task-oriented Treatment in Stroke
- ClinicalTrials.gov ID
- NCT06840132
- Acronym / sponsor ID
- Balıkesir Atatürk CityHospital
- Conditions
- Stroke
- Keywords
- stroke, foot orthoses, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Collaborators
- Balikesir Ataturk City Hospital
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 21 Feb 2025 (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.
A stroke is a neurological condition and a major cause of disability in adults. It occurs suddenly and causes specific brain function problems, leading to noticeable symptoms that last for more than 24 hours.Stroke commonly causes impairments in sensory, motor, and cognitive functions. Approximately 80% of patients experience motor deficits in the lower extremities, often accompanied by balance disturbance (3). Traditionally, neurodevelopmental treatments aimed at restoring normal movement patterns have been used in stroke rehabilitation. However, research on both animals and humans has shown that this approach alone is insufficient. These studies have shown that task-oriented functional exercise training can induce changes in activation patterns in a large portion of the damaged brain areas, leading to restoration of function (4, 5). Engaging in meaningful and repetitive goal-directed functional tasks can effectively enhance neuroplasticity and facilitate recovery.
Task-oriented training is an exercise therapy designed for stroke patients, based on motor learning theory, which emphasizes the repetition of motor skills and aims to enhance performance through meaningful tasks . Lord et al. were the first researchers to conceptually apply task-oriented training, using a total of 19 different functional exercises in their study. They found that both deficiency-based and task-oriented training showed similar results in terms of improving walking and balance skills. However, more recent studies have shown that task-specific, task-oriented treatment programs are superior to traditional facilitation-based therapeutic approaches. Another study comparing conventional physiotherapy, task-oriented group training, and individual task-oriented training, with the aim of assessing the effects of exercises, demonstrated that task-oriented group training led to better outcomes in tasks such as sitting, standing, overcoming obstacles, circular walking, and carrying objects.
Two others found that the foot was more dorsiflexed at higher stiffnesses during initial contact in patients post- stroke An Ankle-Foot Orthosis (AFO) plays a crucial role in individuals with paralysis during walking, particularly in the heel strike and loading phases, by restraining plantar flexion and assisting the impaired function of the dorsiflexors. In individuals with paralysis, dorsiflexion, the upward movement of the ankle, is often weakened or lost. The AFO helps address this issue by maintaining the desired position of the ankle joint, contributing to the preservation of normal gait during walking.
Additionally, during the swing phase (when the leg moves forward), the AFO helps maintain the ankle joint position, supporting toe-off. This enhances walking efficiency and provides stability during the step. Thus, the AFO not only offers support but also significantly contributes to functional improvement, greatly enhancing the walking ability of individuals with paralysis.
Combined use of task-oriented training and orthoses are typically focused on the upper extremity functions rather than the lower extremity functions in patients with stroke. Therefore, in this study, it was aimed to investigate the effects of task-oriented training with and without an ankle-foot orthosis (AFO) on lower extremity function in individuals with stroke. It was hypothesized that task-oriented training with an AFO would lead to greater improvements in lower extremity function such as balance, walking, and stability and quality of life in stroke patients.
The study included 40 individuals with stroke. The inclusion criteria of the study were as follows: aged 18 and older, who had experienced their first stroke, Brunnstrom lower extremity score of ≥3, a Functional Ambulation Classification score of ≥2, at least 3 months post-stroke, and having no other neurological disorders. The individuals will be diagnosed at the Physical Therapy and Rehabilitation outpatient clinic of Balıkesir Atatürk City Hospital by the same neurologist and received treatment at the hospital's rehabilitation department.All patients participated in an intensive physical therapy program for 1 hour per day, 5 days a week, over a period of 4 weeks. For GoPT, a 7-station exercise protocol designed, consisting of motor activities progressing from easy to difficult, with the goal of transforming these activities into permanent skills through meaningful tasks. Participants randomly divided into two groups: the task-oriented physical therapy group (GoPT) (n=19), the task-oriented program plus plastic static ankle-foot orthosis group (GoPT+AFO) (n=20). All participants in the groups were evaluated by a physiotherapist before treatment and after the 4-week intervention period.Six-Minute Walk Test, 10-Meter Walk Test,Timed Up and Go Test,Berg Balance Scale, Functional Reach Test,Stroke Impact Scale were evaluated.
Detailed description
Before starting the study, an application was made to Balıkesir University Non-Interventional Clinical Research Ethics Committee. Usage started with the permission of the ethics committee, decision dated 13.12.2017 and 2017/156.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the task-oriented training | Active comparator | Procedure: Exercisepatients participated in an intensive physical therapy program for 1 hour per day, 5 days a week, over a period of 4 weeks. For GoPT, a 7-station exercise protocol was designed, consisting of motor activities progressing from easy to difficult, with the goal of transforming these activities into permanent skills through meaningful tasks. Each station aimed to gradually improve the patient's motor abilities. Patients were allowed to rest between tasks, and the difficulty of the tasks progressively increased based on each patient's capacity. This 7-station protocol was designed for the first time by our own research team, and the details of the GoPT program |
| the task-oriented training plus plastic static ankle-foot orthosis group | Active comparator | Procedure: Exercisepatients participated in an intensive physical therapy program for 1 hour per day, 5 days a week, over a period of 4 weeks. group using plastic static ankle-foot orthoses (GoPT+AFO) performed the same 7-station exercise protocol as the GoPT group. However, participants in this group were required to wear custom-made plastic static ankle-foot orthoses while completing the exercises. Both the patients and their families were educated on the proper use of the orthosis and encouraged to wear it in daily life as well. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 and older,
- Who had experienced their first stroke,
- Brunnstrom lower extremity score of ≥3,
- Functional Ambulation Classification score of ≥2,
- At least 3 months post-stroke,
Key exclusion criteria (2 listed)
- Under 18 age,
- Having an another neurologic disorder
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 |
|---|---|---|
| ExerciseAlso: task oriented exercise therapy7-station exercise protocol was designed, consisting of motor activities progressing from easy to difficult, with the goal of transforming these activities into permanent skills through meaningful tasks. Each station aimed to gradually improve the patient's motor abilities. Patients were allowed to rest between tasks, and the difficulty of the tasks progressively increased based on each patient's capacity. This 7-station protocol was designed for the first time by our own research team | Procedure or surgery | the task-oriented training |
| ExerciseAlso: task oriented training + orthosesIn addition to the task-oriented training program, the group using plastic static ankle-foot orthoses performed the same 7-station exercise protocol as the task oriented training group. However, participants in this group were required to wear custom-made plastic static ankle-foot orthoses while completing the exercises. | Procedure or surgery | the task-oriented training plus plastic static ankle-foot orthosis group |
Primary outcome
six meter walk
Time frame: from enrollement to the end of four weeks
endurance test. It is assessed by having the person walk continuously for 6 minutes at the maximum speed they can walk in a 30-meter area. The distance walked during this time is recorded. Increased walking distance is perceived positively
1 secondary outcome
berg balance scale
Time frame: from enrollement to the end of 4 weeks
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 6 Mar 2025.
- Results publication: PubMed 25642055Song HS, Kim JY, Park SD. The effect of class-based task-oriented circuit training on the self-satisfaction of patients with chronic stroke. J Phys Ther Sci. 2015 Jan;27(1):127-9. doi: 10.1589/jpts.27.127. Epub 2015 Jan 9.
- Results publication: PubMed 27841442French B, Thomas LH, Coupe J, McMahon NE, Connell L, Harrison J, Sutton CJ, Tishkovskaya S, Watkins CL. Repetitive task training for improving functional ability after stroke. Cochrane Database Syst Rev. 2016 Nov 14;11(11):CD006073. doi: 10.1002/14651858.CD006073.pub3.
- Results publication: PubMed 33501848Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.
- 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.
sezen dincer, asst prof principal investigator
ankara medipol univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Stroke, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
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 6 inclusion and 2 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 6 Mar 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 Turkey (Türkiye). 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?
six meter walk (time frame: from enrollement to the end of four weeks). 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 NCT06840132, which also lists 3 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 6 Mar 2025; AzTrials last refreshed its copy on 3 Nov 2026.