Above Knee AmputationNCT07265154
Gait Training and Balance Using Artificial Intelligence
A study testing Artificial Intelligence in people with Above Knee Amputation and Amputation, run by South Valley University at 1 site in Egypt.
Trial summary
Effect of Using Artificial Intelligence on Gait Training and Balance in Above Knee Amputation Patients Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Above Knee Amputation, Amputation
- What is being tested?
- Artificial Intelligence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients have above-knee amputations.
- All patients have no other neurological diseases affecting gait.
- All patients have no other neurological diseases affecting muscle balance.
- All patients have no other complications affecting joint ROM.
Who cannot join
- Patients have any complications affecting joint ROM.
- Patients have any neurological condition affecting muscle balance.
- Patients have any neurological condition affecting gait.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy,
Banhā, Benha, 83523
Mohammed Ali, PhD, 01011212425, m.essam@svu.edu.eg
m.essam@svu.edu.eg
About this study
Official title: Gait Training and Balance in Above Knee Amputation Patients Using Artificial Intelligence
Effect of Using Artificial Intelligence on Gait Training and Balance in Above Knee Amputation Patients
- Conditions
- Above Knee Amputation, Amputation
- Being tested
- Artificial Intelligence
- Keywords
- Amputation, Above Knee Amputation, Artificial Intelligence, Gait training, Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial IntelligenceDevice
using artificial intelligence in gait and balance training for above knee amputee
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Gait and Balance Training Using Artificial Intelligence Receives: Device: Artificial Intelligence |
| group B | No intervention | Traditional Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medio-lateral Stability Index (MLSI)
Medio-lateral Stability Index (MLSI) represents fluctuations from the horizontal around the mediolateral axis
Measured: Day 0, Day 90
Anterior-posterior Stability Index (APSI)
Anterior-posterior Stability Index (APSI) represents fluctuations from the horizontal around the anteroposterior axis
Measured: Day 0, Day 90
Overall Stability Index (OSI)
Overall Stability Index (OSI) a composite of MLSI and APSI so it is sensitive to changes in both directions
Measured: Day 0, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Jun 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Above Knee AmputationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Collaborators
- Badr University, Benha University, Al Salam University
- Responsible party
- Principal investigator, Mohammed E. Ali, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265154
- Sponsor's protocol ID
- P.T.REC/012/004661
- Status last verified
- Aug 2026
- First submitted
- 23 Nov 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hartley H, Cassidy E, Bunn L, Kumar R, Pizer B, Lane S, Carter B. Exercise and Physical Therapy Interventions for Children with Ataxia: A Systematic Review. Cerebellum. 2019 Oct;18(5):951-968. doi: 10.1007/s12311-019-01063-z.
PubMed 31392562Tatla SK, Radomski A, Cheung J, Maron M, Jarus T. Wii-habilitation as balance therapy for children with acquired brain injury. Dev Neurorehabil. 2014 Feb;17(1):1-15. doi: 10.3109/17518423.2012.740508. Epub 2012 Dec 11.
PubMed 232313771. Nehad A. Abo-Zaid, Nesma A Helmy, Nader I Elsayed, Amira H Mohammed. Wii Sport versus task-oriented training on gait in unilateral cerebral palsy: A randomized controlled trial. Conference: Journal of Human Sport and Exercise. Autumn Conferences of Sports Science2021.16. Proc2.36, doi: 10.14198/jhse.
Abo-Zaid NA, El-Gendy AM, Hewidy I, Essam Ali M, Sabbahi A. Influence of aerobic exercise on inhibitory control of executive functions in children with hemiplegic cerebral palsy: A randomized controlled trial. Clin Rehabil. 2024 Mar;38(3):337-346. doi: 10.1177/02692155231208578. Epub 2023 Oct 26.
PubMed 3788522127. Nehad A Abo-zaid, Hebatallah M Zaghloul, Heba A Khalifa., Mohammed E Ali, Mohamed Y Abdelsamee. Efficacy of Lower Extremity Mirror Therapy on Balance in Children with Hemiplegic Cerebral Palsy: A Randomized Controlled Trial International Journal of Psychosocial Rehabilitation, 2020, Vol. 24, Issue 08
Nolan L, Grigorenko A, Thorstensson A. Balance control: sex and age differences in 9- to 16-year-olds. Dev Med Child Neurol. 2005 Jul;47(7):449-54. doi: 10.1017/s0012162205000873.
PubMed 15991864Kitago T, Krakauer JW. Motor learning principles for neurorehabilitation. Handb Clin Neurol. 2013;110:93-103. doi: 10.1016/B978-0-444-52901-5.00008-3.
PubMed 23312633Dewar R, Love S, Johnston LM. Exercise interventions improve postural control in children with cerebral palsy: a systematic review. Dev Med Child Neurol. 2015 Jun;57(6):504-20. doi: 10.1111/dmcn.12660. Epub 2014 Dec 18.
PubMed 2552341045. Rafaela Ribeiro da Silva, Cristina Iwabe-Marchese. Using virtual reality for motor rehabilitation in a child with ataxic cerebral palsy: case report. Fisioter Pesq. 2015; 22(1):97-102, doi.org/10.590/1809-2950/13375322012015
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Training and Balance in Above Knee Amputation Patients Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07265154
- Acronym / sponsor ID
- P.T.REC/012/004661
- Conditions
- Above Knee Amputation, Amputation
- Keywords
- Amputation, Above Knee Amputation, Artificial Intelligence, Gait training, Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Collaborators
- Badr University, Benha University, Al Salam University
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 4 Dec 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.
Effect of Using Artificial Intelligence on Gait Training and Balance in Above Knee Amputation Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Device: Artificial IntelligenceGait and Balance Training Using Artificial Intelligence |
| group B | No intervention | –Traditional Physical Therapy Program |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All patients have above-knee amputations.
- All patients have no other neurological diseases affecting gait.
- All patients have no other neurological diseases affecting muscle balance.
- All patients have no other complications affecting joint ROM.
Key exclusion criteria (3 listed)
- Patients have any complications affecting joint ROM.
- Patients have any neurological condition affecting muscle balance.
- Patients have any neurological condition affecting gait.
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 |
|---|---|---|
| Artificial Intelligenceusing artificial intelligence in gait and balance training for above knee amputee | Device | group A |
Primary outcome
Medio-lateral Stability Index (MLSI)
Time frame: Day 0, Day 90
Medio-lateral Stability Index (MLSI) represents fluctuations from the horizontal around the mediolateral axis
Anterior-posterior Stability Index (APSI)
Time frame: Day 0, Day 90
Anterior-posterior Stability Index (APSI) represents fluctuations from the horizontal around the anteroposterior axis
Overall Stability Index (OSI)
Time frame: Day 0, Day 90
Overall Stability Index (OSI) a composite of MLSI and APSI so it is sensitive to changes in both directions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Results publication: PubMed 31392562Hartley H, Cassidy E, Bunn L, Kumar R, Pizer B, Lane S, Carter B. Exercise and Physical Therapy Interventions for Children with Ataxia: A Systematic Review. Cerebellum. 2019 Oct;18(5):951-968. doi: 10.1007/s12311-019-01063-z.
- Results publication: PubMed 23231377Tatla SK, Radomski A, Cheung J, Maron M, Jarus T. Wii-habilitation as balance therapy for children with acquired brain injury. Dev Neurorehabil. 2014 Feb;17(1):1-15. doi: 10.3109/17518423.2012.740508. Epub 2012 Dec 11.
- Results publication1. Nehad A. Abo-Zaid, Nesma A Helmy, Nader I Elsayed, Amira H Mohammed. Wii Sport versus task-oriented training on gait in unilateral cerebral palsy: A randomized controlled trial. Conference: Journal of Human Sport and Exercise. Autumn Conferences of Sports Science2021.16. Proc2.36, doi: 10.14198/jhse.
- Results publication: PubMed 37885221Abo-Zaid NA, El-Gendy AM, Hewidy I, Essam Ali M, Sabbahi A. Influence of aerobic exercise on inhibitory control of executive functions in children with hemiplegic cerebral palsy: A randomized controlled trial. Clin Rehabil. 2024 Mar;38(3):337-346. doi: 10.1177/02692155231208578. Epub 2023 Oct 26.
- Results publication27. Nehad A Abo-zaid, Hebatallah M Zaghloul, Heba A Khalifa., Mohammed E Ali, Mohamed Y Abdelsamee. Efficacy of Lower Extremity Mirror Therapy on Balance in Children with Hemiplegic Cerebral Palsy: A Randomized Controlled Trial International Journal of Psychosocial Rehabilitation, 2020, Vol. 24, Issue 08
- Results publication: PubMed 15991864Nolan L, Grigorenko A, Thorstensson A. Balance control: sex and age differences in 9- to 16-year-olds. Dev Med Child Neurol. 2005 Jul;47(7):449-54. doi: 10.1017/s0012162205000873.
- Results publication: PubMed 23312633Kitago T, Krakauer JW. Motor learning principles for neurorehabilitation. Handb Clin Neurol. 2013;110:93-103. doi: 10.1016/B978-0-444-52901-5.00008-3.
- Results publication: PubMed 25523410Dewar R, Love S, Johnston LM. Exercise interventions improve postural control in children with cerebral palsy: a systematic review. Dev Med Child Neurol. 2015 Jun;57(6):504-20. doi: 10.1111/dmcn.12660. Epub 2014 Dec 18.
- Results publication45. Rafaela Ribeiro da Silva, Cristina Iwabe-Marchese. Using virtual reality for motor rehabilitation in a child with ataxic cerebral palsy: case report. Fisioter Pesq. 2015; 22(1):97-102, doi.org/10.590/1809-2950/13375322012015
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence in people with Above Knee Amputation and Amputation, run by South Valley University at 1 site in Egypt.
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 3 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed E. Ali, PhD (+201011212425, m.essam@svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medio-lateral Stability Index (MLSI) (time frame: Day 0, Day 90). The study lists 3 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 NCT07265154, which also lists 9 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 18 Aug 2026.