Upper Extremity DysfunctionNCT04671524
The Effect of Improvement in Function on Foot Pressure, Balance and Gait in Children With Upper Extremity Affected
A study testing Exercise protocol in people with Upper Extremity Dysfunction and Gait, Unsteady, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
It has been shown that movements of the upper extremity during walking are associated with lower extremity mobility. For example, when walking at a slow pace, the swing frequency of the arms is 2: 1 compared to the legs, while the limb frequency decreases to 1: 1 as the walking speed increases. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Extremity Dysfunction, Gait, Unsteady, Juvenile Idiopathic Arthritis
- What is being tested?
- Exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2020to 1 Jul 2021
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- To be in the 10-18 ages group (In order for the devices to comply with the minimum measurement criteria and to be able to cooperate with the study)
- Being diagnosed with rheumatic diseases at least 6 months ago with only upper extremity affected
- Unilateral upper extremity involvement
Who cannot join
- Having an acute pathology that could affect walking
- To be diagnosed with orthopedic/neurological pathology that will affect work and cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Improvement in Function on Foot Pressure, Balance and Gait in Children With Rheumatic Diseases Whose Upper Extremity Affected
It has been shown that movements of the upper extremity during walking are associated with lower extremity mobility. For example, when walking at a slow pace, the swing frequency of the arms is 2: 1 compared to the legs, while the limb frequency decreases to 1: 1 as the walking speed increases. That is, in order to walk fast, the lower extremity takes advantage of the acceleration of the upper extremity [1]. It is known that the muscles of the shoulder girdle also support this oscillating movement in the upper extremity during walking. Thus, it is thought that blocking or restricting shoulder girdle and arm movements during walking increases energy expenditure and heart rate, decreases gait stability, and decreases stride length and walking speed [2,3]. However, the possible effects that the upper limb can aid in movement include decreasing vertical displacement of the center of mass, decreasing angular momentum or decreasing ground reaction moment, and increasing walking stability [2-4]. In these studies that restrict arm swing, methods such as crossing the arms on the chest [5], holding the arm in a sling or pocket [6], or fixing the arms to the trunk with a bandage [7] were used. Studies have generally been conducted on healthy individuals or on the biomechanical model, and arm swing during walking has not been investigated in pathologies with only upper extremity involvement (upper extremity fractures, Juvenile Idiopathic Arthritis) without any problems with lower extremity and/or walking.
This study is aimed to reveal the effects of decreased upper extremity functionality on walking and balance.
Read the detailed description
It has been shown that movements of the upper extremity during walking are associated with lower extremity mobility. For example, when walking at a slow pace, the swing frequency of the arms is 2: 1 compared to the legs, while the limb frequency decreases to 1: 1 as the walking speed increases. That is, in order to walk fast, the lower extremity takes advantage of the acceleration of the upper extremity [1]. It is known that the muscles of the shoulder girdle also support this oscillating movement in the upper extremity during walking. Thus, it is thought that blocking or restricting shoulder girdle and arm movements during walking increases energy expenditure and heart rate, decreases gait stability, and decreases stride length and walking speed [2,3]. However, the possible effects that the upper limb can aid in the movement include decreasing vertical displacement of the center of mass, decreasing angular momentum or decreasing ground reaction moment, and increasing walking stability [2-4]. In these studies that restrict arm swing, methods such as crossing the arms on the chest [5], holding the arm in a sling or pocket [6], or fixing the arms to the trunk with a bandage [7] were used. Studies have generally been conducted on healthy individuals or on the biomechanical model, and arm swing during walking has not been investigated in pathologies with only upper extremity involvement (upper extremity fractures, Juvenile Idiopathic Arthritis) without any problems with lower extremity and/or walking.
Studies performed in pathologies where upper extremity mobility and arm swing are affected have shown that the kinetic and kinematic parameters of walking are also affected [8-11]. This change in walking dynamics also changes foot pressure behavior. In a study investigating the effect of arm swing on the affected side on walking in hemiplegic individuals, ground reaction forces on the affected and unaffected sides by foot pressure analysis were examined and it was found that the maximum forces applied during the first contact and toe-off on both sides decreased [12]. In addition, the stance phase duration was higher in hemiplegic patients compared to healthy controls in both lower extremities [12]. This suggests that the affected upper extremity may change the time to transfer weight while walking. In a study investigating the changes in gait parameters in patients with brachial plexus [13] in which ground reaction forces were examined, different gait phase durations and maximum ground reaction force times were found in the affected lower extremity compared to the unaffected side. In a study examining whether the degree of upper extremity functionality has an effect on walking in patients with hemiparetic cerebral palsy; Patients were included in the exercise program aimed at increasing upper extremity function, and as a result, it was found that while upper extremity function increased, patients improved walking parameters and walking distance [14]. Zhou et al. investigated the effects of an active upper extremity exercise program in patients with spinal cord injuries and demonstrated the usefulness of active upper extremity participation in walking [15].
With these results in the literature, the effect of reduced upper extremity function on gait and balance in disease groups (such as rheumatic diseases with only upper extremity involvement, upper extremity fractures) without affecting walking or any neurological/orthopedic diagnosis that may affect walking was not investigated.
The aim of this study is to reveal the effects of decreased upper extremity functionality on walking and balance.
- Being tested
- Exercise protocol
- Keywords
- Upper Extremity, Physiotherapy, Exercise, Gait, Balance
- Medical subject headings
- Gait Disorders, Neurologic, Arthritis, Juvenile, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise protocolOther
a combination of stretching, range of motion, and strengthening exercise.
| Study group | Role | What they receive |
|---|---|---|
| pediatric patients diagnosed with rheumatic diseases. | Experimental | Exercise group; a combination of stretching, range of motion, and strengthening exercise.
The exercise program will take 8 weeks, 3 days per week, and 45 minutes. Receives: Other: Exercise protocol |
| healthy controls | No intervention | The healthy control group will be examined and the outcomes will be compared with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall risk
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at two different conditions, eyes open comfortable stance and eyes closed comfortable stance. The outcome is the sway variation index (SVI).
Measured: immediately after exercise protocol
Postural Stability
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at one condition, eyes open, and automatic foot placement stance. The outcome is the stability index.
Measured: immediately after exercise protocol
Bilateral Comparison
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at two different conditions, the right leg stance and left leg stance. The outcome is the sway index.
Measured: immediately after exercise protocol
Single limb stance
This outcome will be evaluated with foot pressure analysis. The time between first and second peak forces during walking is the single-limb stance duration.
Measured: immediately after exercise protocol
Secondary outcomes (2)
Arm Swing Amplitude
The difference between the maximum flexion and extension of the shoulder is the arm swing amplitude during walking. The arm swing amplitude will be evaluated 2-dimensionally with the help of the Kinovea video player.
Measured: immediately after exercise protocol
Jebsen-Taylor Hand Function Test
The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). The outcome is the sum of time taken for each sub-test, which is rounded to the nearest second.
Measured: immediately after exercise protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Sep 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity DysfunctionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokce Leblebici, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671524
- Sponsor's protocol ID
- IstanbulUC_34_2
- Status last verified
- Apr 2022
- First submitted
- 5 Dec 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wagenaar RC, van Emmerik RE. Resonant frequencies of arms and legs identify different walking patterns. J Biomech. 2000 Jul;33(7):853-61. doi: 10.1016/s0021-9290(00)00020-8.
PubMed 10831760Bruijn SM, Meijer OG, Beek PJ, van Dieen JH. The effects of arm swing on human gait stability. J Exp Biol. 2010 Dec 1;213(Pt 23):3945-52. doi: 10.1242/jeb.045112.
PubMed 21075935Meyns P, Bruijn SM, Duysens J. The how and why of arm swing during human walking. Gait Posture. 2013 Sep;38(4):555-62. doi: 10.1016/j.gaitpost.2013.02.006. Epub 2013 Mar 13.
PubMed 23489950Collins SH, Adamczyk PG, Kuo AD. Dynamic arm swinging in human walking. Proc Biol Sci. 2009 Oct 22;276(1673):3679-88. doi: 10.1098/rspb.2009.0664. Epub 2009 Jul 29.
PubMed 19640879Pontzer H, Holloway JH 4th, Raichlen DA, Lieberman DE. Control and function of arm swing in human walking and running. J Exp Biol. 2009 Feb;212(Pt 4):523-34. doi: 10.1242/jeb.024927.
PubMed 19181900Kuhtz-Buschbeck JP, Jing B. Activity of upper limb muscles during human walking. J Electromyogr Kinesiol. 2012 Apr;22(2):199-206. doi: 10.1016/j.jelekin.2011.08.014. Epub 2011 Sep 25.
PubMed 21945656Yizhar Z, Boulos S, Inbar O, Carmeli E. The effect of restricted arm swing on energy expenditure in healthy men. Int J Rehabil Res. 2009 Jun;32(2):115-23. doi: 10.1097/MRR.0b013e32830d3675.
PubMed 19065107Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
PubMed 10869131Meyns P, Van Gestel L, Massaad F, Desloovere K, Molenaers G, Duysens J. Arm swing during walking at different speeds in children with Cerebral Palsy and typically developing children. Res Dev Disabil. 2011 Sep-Oct;32(5):1957-64. doi: 10.1016/j.ridd.2011.03.029. Epub 2011 May 4.
PubMed 21531534Stephenson JL, Lamontagne A, De Serres SJ. The coordination of upper and lower limb movements during gait in healthy and stroke individuals. Gait Posture. 2009 Jan;29(1):11-6. doi: 10.1016/j.gaitpost.2008.05.013. Epub 2008 Jul 11.
PubMed 18620861Ford MP, Wagenaar RC, Newell KM. Arm constraint and walking in healthy adults. Gait Posture. 2007 Jun;26(1):135-41. doi: 10.1016/j.gaitpost.2006.08.008. Epub 2006 Sep 25.
PubMed 16997561Kim HD, Kim JG, Jeon DM, Shin MH, Han N, Eom MJ, Jo GY. Analysis of Vertical Ground Reaction Force Variables Using Foot Scans in Hemiplegic Patients. Ann Rehabil Med. 2015 Jun;39(3):409-15. doi: 10.5535/arm.2015.39.3.409. Epub 2015 Jun 30.
PubMed 26161347Grodner MR, Dudzinski K, Zdrajkowski Z, Molik A, Nosarzewska A. Selected gait parameters in children with obstetric brachial plexus injury (OBPI) - a pilot study. Ortop Traumatol Rehabil. 2012 Nov-Dec;14(6):555-68. doi: 10.5604/15093492.1024721.
PubMed 23382283Cohen-Holzer M, Sorek G, Schless S, Kerem J, Katz-Leurer M. The Influence of a Constraint and Bimanual Training Program Using a Variety of Modalities, on Upper Extremity Functions and Gait Parameters Among Children with Hemiparetic Cerebral Palsy: A Case Series. Phys Occup Ther Pediatr. 2016;36(1):17-27. doi: 10.3109/01942638.2014.990549. Epub 2014 Dec 18.
PubMed 25521486Zhou R, Alvarado L, Ogilvie R, Chong SL, Shaw O, Mushahwar VK. Non-gait-specific intervention for the rehabilitation of walking after SCI: role of the arms. J Neurophysiol. 2018 Jun 1;119(6):2194-2211. doi: 10.1152/jn.00569.2017. Epub 2018 Jan 24.
PubMed 29364074
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Improvement in Function on Foot Pressure, Balance and Gait in Children With Rheumatic Diseases Whose Upper Extremity Affected
- ClinicalTrials.gov ID
- NCT04671524
- Acronym / sponsor ID
- IstanbulUC_34_2
- Keywords
- Upper Extremity, Physiotherapy, Exercise, Gait, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 17 Dec 2020 (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.
It has been shown that movements of the upper extremity during walking are associated with lower extremity mobility. For example, when walking at a slow pace, the swing frequency of the arms is 2: 1 compared to the legs, while the limb frequency decreases to 1: 1 as the walking speed increases. That is, in order to walk fast, the lower extremity takes advantage of the acceleration of the upper extremity [1]. It is known that the muscles of the shoulder girdle also support this oscillating movement in the upper extremity during walking. Thus, it is thought that blocking or restricting shoulder girdle and arm movements during walking increases energy expenditure and heart rate, decreases gait stability, and decreases stride length and walking speed [2,3]. However, the possible effects that the upper limb can aid in movement include decreasing vertical displacement of the center of mass, decreasing angular momentum or decreasing ground reaction moment, and increasing walking stability [2-4]. In these studies that restrict arm swing, methods such as crossing the arms on the chest [5], holding the arm in a sling or pocket [6], or fixing the arms to the trunk with a bandage [7] were used. Studies have generally been conducted on healthy individuals or on the biomechanical model, and arm swing during walking has not been investigated in pathologies with only upper extremity involvement (upper extremity fractures, Juvenile Idiopathic Arthritis) without any problems with lower extremity and/or walking.
This study is aimed to reveal the effects of decreased upper extremity functionality on walking and balance.
Detailed description
It has been shown that movements of the upper extremity during walking are associated with lower extremity mobility. For example, when walking at a slow pace, the swing frequency of the arms is 2: 1 compared to the legs, while the limb frequency decreases to 1: 1 as the walking speed increases. That is, in order to walk fast, the lower extremity takes advantage of the acceleration of the upper extremity [1]. It is known that the muscles of the shoulder girdle also support this oscillating movement in the upper extremity during walking. Thus, it is thought that blocking or restricting shoulder girdle and arm movements during walking increases energy expenditure and heart rate, decreases gait stability, and decreases stride length and walking speed [2,3]. However, the possible effects that the upper limb can aid in the movement include decreasing vertical displacement of the center of mass, decreasing angular momentum or decreasing ground reaction moment, and increasing walking stability [2-4]. In these studies that restrict arm swing, methods such as crossing the arms on the chest [5], holding the arm in a sling or pocket [6], or fixing the arms to the trunk with a bandage [7] were used. Studies have generally been conducted on healthy individuals or on the biomechanical model, and arm swing during walking has not been investigated in pathologies with only upper extremity involvement (upper extremity fractures, Juvenile Idiopathic Arthritis) without any problems with lower extremity and/or walking.
Studies performed in pathologies where upper extremity mobility and arm swing are affected have shown that the kinetic and kinematic parameters of walking are also affected [8-11]. This change in walking dynamics also changes foot pressure behavior. In a study investigating the effect of arm swing on the affected side on walking in hemiplegic individuals, ground reaction forces on the affected and unaffected sides by foot pressure analysis were examined and it was found that the maximum forces applied during the first contact and toe-off on both sides decreased [12]. In addition, the stance phase duration was higher in hemiplegic patients compared to healthy controls in both lower extremities [12]. This suggests that the affected upper extremity may change the time to transfer weight while walking. In a study investigating the changes in gait parameters in patients with brachial plexus [13] in which ground reaction forces were examined, different gait phase durations and maximum ground reaction force times were found in the affected lower extremity compared to the unaffected side. In a study examining whether the degree of upper extremity functionality has an effect on walking in patients with hemiparetic cerebral palsy; Patients were included in the exercise program aimed at increasing upper extremity function, and as a result, it was found that while upper extremity function increased, patients improved walking parameters and walking distance [14]. Zhou et al. investigated the effects of an active upper extremity exercise program in patients with spinal cord injuries and demonstrated the usefulness of active upper extremity participation in walking [15].
With these results in the literature, the effect of reduced upper extremity function on gait and balance in disease groups (such as rheumatic diseases with only upper extremity involvement, upper extremity fractures) without affecting walking or any neurological/orthopedic diagnosis that may affect walking was not investigated.
The aim of this study is to reveal the effects of decreased upper extremity functionality on walking and balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pediatric patients diagnosed with rheumatic diseases. | Experimental | Other: Exercise protocolExercise group; a combination of stretching, range of motion, and strengthening exercise. The exercise program will take 8 weeks, 3 days per week, and 45 minutes. |
| healthy controls | No intervention | –The healthy control group will be examined and the outcomes will be compared with the experimental group. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- To be in the 10-18 ages group (In order for the devices to comply with the minimum measurement criteria and to be able to cooperate with the study)
- Being diagnosed with rheumatic diseases at least 6 months ago with only upper extremity affected
- Unilateral upper extremity involvement
Key exclusion criteria (2 listed)
- Having an acute pathology that could affect walking
- To be diagnosed with orthopedic/neurological pathology that will affect work and cooperation
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 |
|---|---|---|
| Exercise protocola combination of stretching, range of motion, and strengthening exercise. | Other | pediatric patients diagnosed with rheumatic diseases. |
Primary outcome
Fall risk
Time frame: immediately after exercise protocol
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at two different conditions, eyes open comfortable stance and eyes closed comfortable stance. The outcome is the sway variation index (SVI).
Postural Stability
Time frame: immediately after exercise protocol
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at one condition, eyes open, and automatic foot placement stance. The outcome is the stability index.
Bilateral Comparison
Time frame: immediately after exercise protocol
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at two different conditions, the right leg stance and left leg stance. The outcome is the sway index.
Single limb stance
Time frame: immediately after exercise protocol
This outcome will be evaluated with foot pressure analysis. The time between first and second peak forces during walking is the single-limb stance duration.
2 secondary outcomes
Arm Swing Amplitude
Time frame: immediately after exercise protocol
Jebsen-Taylor Hand Function Test
Time frame: immediately after exercise protocol
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 5 Apr 2022.
- Background: PubMed 10831760Wagenaar RC, van Emmerik RE. Resonant frequencies of arms and legs identify different walking patterns. J Biomech. 2000 Jul;33(7):853-61. doi: 10.1016/s0021-9290(00)00020-8.
- Background: PubMed 21075935Bruijn SM, Meijer OG, Beek PJ, van Dieen JH. The effects of arm swing on human gait stability. J Exp Biol. 2010 Dec 1;213(Pt 23):3945-52. doi: 10.1242/jeb.045112.
- Background: PubMed 23489950Meyns P, Bruijn SM, Duysens J. The how and why of arm swing during human walking. Gait Posture. 2013 Sep;38(4):555-62. doi: 10.1016/j.gaitpost.2013.02.006. Epub 2013 Mar 13.
- Background: PubMed 19640879Collins SH, Adamczyk PG, Kuo AD. Dynamic arm swinging in human walking. Proc Biol Sci. 2009 Oct 22;276(1673):3679-88. doi: 10.1098/rspb.2009.0664. Epub 2009 Jul 29.
- Background: PubMed 19181900Pontzer H, Holloway JH 4th, Raichlen DA, Lieberman DE. Control and function of arm swing in human walking and running. J Exp Biol. 2009 Feb;212(Pt 4):523-34. doi: 10.1242/jeb.024927.
- Background: PubMed 21945656Kuhtz-Buschbeck JP, Jing B. Activity of upper limb muscles during human walking. J Electromyogr Kinesiol. 2012 Apr;22(2):199-206. doi: 10.1016/j.jelekin.2011.08.014. Epub 2011 Sep 25.
- Background: PubMed 19065107Yizhar Z, Boulos S, Inbar O, Carmeli E. The effect of restricted arm swing on energy expenditure in healthy men. Int J Rehabil Res. 2009 Jun;32(2):115-23. doi: 10.1097/MRR.0b013e32830d3675.
- Background: PubMed 10869131Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
- Background: PubMed 21531534Meyns P, Van Gestel L, Massaad F, Desloovere K, Molenaers G, Duysens J. Arm swing during walking at different speeds in children with Cerebral Palsy and typically developing children. Res Dev Disabil. 2011 Sep-Oct;32(5):1957-64. doi: 10.1016/j.ridd.2011.03.029. Epub 2011 May 4.
- Background: PubMed 18620861Stephenson JL, Lamontagne A, De Serres SJ. The coordination of upper and lower limb movements during gait in healthy and stroke individuals. Gait Posture. 2009 Jan;29(1):11-6. doi: 10.1016/j.gaitpost.2008.05.013. Epub 2008 Jul 11.
- Background: PubMed 16997561Ford MP, Wagenaar RC, Newell KM. Arm constraint and walking in healthy adults. Gait Posture. 2007 Jun;26(1):135-41. doi: 10.1016/j.gaitpost.2006.08.008. Epub 2006 Sep 25.
- Background: PubMed 26161347Kim HD, Kim JG, Jeon DM, Shin MH, Han N, Eom MJ, Jo GY. Analysis of Vertical Ground Reaction Force Variables Using Foot Scans in Hemiplegic Patients. Ann Rehabil Med. 2015 Jun;39(3):409-15. doi: 10.5535/arm.2015.39.3.409. Epub 2015 Jun 30.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 protocol in people with Upper Extremity Dysfunction and Gait, Unsteady, run by Istanbul University - Cerrahpasa 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 3 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 5 Apr 2022. 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?
Fall risk (time frame: immediately after exercise protocol). The study lists 4 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 NCT04671524, which also lists 15 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 5 Apr 2022.