Physical TherapyNCT07027215
Augmented Sensory in Cancer-Related Neuropathic Patients"
A study testing Gradual Intermittent pneumatic compression therapy (IPC),Balance excercises.PNF technique and selected physical therapy program as arm excercises in people with Physical Therapy, run by Isra University, Jordan at 1 site in Egypt.
Trial summary
this research studied the effect of augmented sensory feedback program on motor control and risk of falling in patient with CIPN. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Physical Therapy
- What is being tested?
- Gradual Intermittent pneumatic compression therapy (IPC),Balance excercises.PNF technique and selected physical therapy program as arm excercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2024to 30 May 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 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Forty female with age from 35-60 years
- clinically diagnosed with CIPN after recovery from stage I or II breast cancer
- The strength at the toes, ankles, knees, and hips, as determined by manual muscle tests, of at least 3/5.
- The patients can walk independently with or without any assistive devices.
Who cannot join
- Patients with a history of hereditary peripheral neuropathy
- Diseases that may contribute to peripheral nerve damage, such as diabetes or renal insufficiency, alcohol abuse, HIV, and vasculitis.
- Patient who had central or peripheral neurologic disease, brain or spinal cord metastases
- Orthopedic problems influencing gait, or foot ulcer at the moment of intake.
- Patients with vestibular or neurological problems influencing gait parameters
- Subjects who had participated in regular exercise, as defined as 150 min of light-to-moderate intensity exercise per week over the past year, were excluded from this trial.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy South Valley University
Luxor, Qena Governorate
About this study
Official title: Impact of Augmented Sensory Feedback on Motor Control and Risk of Falling in Cancer-Related Neuropathic Patients"
this research studied the effect of augmented sensory feedback program on motor control and risk of falling in patient with CIPN.
Read the detailed description
Design: A randomized control trial was conducted to investigate the impact of augmented sensory feedback paradigm on motor control and risk of falling in patient with Chemotherapy-induced peripheral neuropathy. Data were collected pre and post treatment from out-patient clinic of the Faculty of Medicine and Faculty of Physical Therapy South Valley University, between January 2023and March 2024. The study was approved by the ethical committee of the Faculty of Physical Therapy, South Vally University, Egypt. The study protocol was explained in detail to every patient and signed written consent was obtained before participation.
Participants: forty female patients with CIPN were recruited from out-patient clinic of the Faculty of Medicine and Faculty of Physical Therapy South Valley University, between January 2023and March 2024.
- Conditions
- Physical Therapy
- Being tested
- Gradual Intermittent pneumatic compression therapy (IPC),Balance excercises.PNF technique, selected physical therapy program as arm excercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gradual Intermittent pneumatic compression therapy (IPC),Balance excercises.PNF techniqueCombination product
Also called Balance Exercises
PNF technique
selected physical therapy program as arm excercisesCombination product
selected physical therapy program only. The program consisted of (core exercises, AROM exercises, and stretching exercises for LL for 18 sessions every other day, over 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| control group 20 Patients" | Active comparator | Cancer-Related Neuropathic Patients" Receives: Combination Product: selected physical therapy program as arm excercises |
| study group 20 Patients" | Active comparator | Cancer-Related Neuropathic Patients" Receives: Combination Product: Gradual Intermittent pneumatic compression therapy (IPC),Balance excercises.PNF technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of balance which was assessed by fall risk scale
improvement in feet sensitivity and motor control and risk of falling in both groups in favor of the study group.
Measured: one and half month
Stability measures
postural stability was measured using a Biodex Balance System SD (950-440 with version 4.X software)
Measured: one and half month
Sensory feedback
Sensory feedback was assessed by using Semmes-Weinstein monofilament (SWM)
Measured: one and half month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start20 Jan 2024
- Primary completion25 Mar 2024
- Study completion30 May 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 Physical TherapyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University, Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Abdrabo, Isra University, Jordan
- Investigators
- Abeer A Mohammed, PhD, Principal investigator, Isra university. Amman.jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027215
- Sponsor's protocol ID
- Augmented Sensory Feedback
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
PubMed 25261162Schneberger S. "Prolife" perinatologist. N Engl J Med. 1992 Sep 10;327(11):812; author reply 813-4. No abstract available.
PubMed 1501662Sienko KH, Seidler RD, Carender WJ, Goodworth AD, Whitney SL, Peterka RJ. Potential Mechanisms of Sensory Augmentation Systems on Human Balance Control. Front Neurol. 2018 Nov 12;9:944. doi: 10.3389/fneur.2018.00944. eCollection 2018.
PubMed 30483209
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Augmented Sensory Feedback on Motor Control and Risk of Falling in Cancer-Related Neuropathic Patients"
- ClinicalTrials.gov ID
- NCT07027215
- Acronym / sponsor ID
- Augmented Sensory Feedback
- Conditions
- Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Isra University, JordanUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 18 Jun 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.
this research studied the effect of augmented sensory feedback program on motor control and risk of falling in patient with CIPN.
Detailed description
Design: A randomized control trial was conducted to investigate the impact of augmented sensory feedback paradigm on motor control and risk of falling in patient with Chemotherapy-induced peripheral neuropathy. Data were collected pre and post treatment from out-patient clinic of the Faculty of Medicine and Faculty of Physical Therapy South Valley University, between January 2023and March 2024. The study was approved by the ethical committee of the Faculty of Physical Therapy, South Vally University, Egypt. The study protocol was explained in detail to every patient and signed written consent was obtained before participation.
Participants: forty female patients with CIPN were recruited from out-patient clinic of the Faculty of Medicine and Faculty of Physical Therapy South Valley University, between January 2023and March 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group 20 Patients" | Active comparator | Combination Product: selected physical therapy program as arm excercisesCancer-Related Neuropathic Patients" |
| study group 20 Patients" | Active comparator | Combination Product: Gradual Intermittent pneumatic compression therapy (IPC),Balance excercises.PNF techniqueCancer-Related Neuropathic Patients" |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Forty female with age from 35-60 years
- clinically diagnosed with CIPN after recovery from stage I or II breast cancer
- The strength at the toes, ankles, knees, and hips, as determined by manual muscle tests, of at least 3/5.
- The patients can walk independently with or without any assistive devices.
Key exclusion criteria (6 listed)
- Patients with a history of hereditary peripheral neuropathy
- Diseases that may contribute to peripheral nerve damage, such as diabetes or renal insufficiency, alcohol abuse, HIV, and vasculitis.
- Patient who had central or peripheral neurologic disease, brain or spinal cord metastases
- Orthopedic problems influencing gait, or foot ulcer at the moment of intake.
- Patients with vestibular or neurological problems influencing gait parameters
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 |
|---|---|---|
| Gradual Intermittent pneumatic compression therapy (IPC),Balance excercises.PNF techniqueAlso: Balance ExercisesPNF technique | Combination product | study group 20 Patients" |
| selected physical therapy program as arm excercisesselected physical therapy program only. The program consisted of (core exercises, AROM exercises, and stretching exercises for LL for 18 sessions every other day, over 6 weeks | Combination product | control group 20 Patients" |
Primary outcome
improvement of balance which was assessed by fall risk scale
Time frame: one and half month
improvement in feet sensitivity and motor control and risk of falling in both groups in favor of the study group.
Stability measures
Time frame: one and half month
postural stability was measured using a Biodex Balance System SD (950-440 with version 4.X software)
Sensory feedback
Time frame: one and half month
Sensory feedback was assessed by using Semmes-Weinstein monofilament (SWM)
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 22 Dec 2025.
- Results publication: PubMed 25261162Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
- Results publication: PubMed 1501662Schneberger S. "Prolife" perinatologist. N Engl J Med. 1992 Sep 10;327(11):812; author reply 813-4. No abstract available.
- Results publication: PubMed 30483209Sienko KH, Seidler RD, Carender WJ, Goodworth AD, Whitney SL, Peterka RJ. Potential Mechanisms of Sensory Augmentation Systems on Human Balance Control. Front Neurol. 2018 Nov 12;9:944. doi: 10.3389/fneur.2018.00944. eCollection 2018.
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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.
Abeer A Mohammed, PhD principal investigator
Isra university. Amman.jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gradual Intermittent pneumatic compression therapy (IPC),Balance excercises.PNF technique and selected physical therapy program as arm excercises in people with Physical Therapy, run by Isra University, Jordan 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 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 22 Dec 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 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?
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?
improvement of balance which was assessed by fall risk scale (time frame: one and half month). 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 NCT07027215, 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 22 Dec 2025.