CIPNNCT05382520
Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)
A study testing Questionares and practice in people with CIPN, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Physiotherapist research about Sensory rehabilitation in chemotherapy induced peripheral neuropathy (CIPN) with the aid of questioners and physiotherapy practice Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- CIPN
- What is being tested?
- Questionares and practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2022to 1 Dec 2025
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over who suffer from chemotherapy-induced neuropathy (CIPN), according to the patient's report, more than 3 months since the end of the chemotherapy treatment.
Who cannot join
- Sensory damage / neuropathy that existed even before the start of chemotherapy
- Incidents of recurrent falls even before the start of chemotherapy (over 2 falls for 6 months)
- Central nervous system involvement
- Major pre-morbid orthopedic lower limb impairment
- Hebrew language not sufficient for assessment and treatment
Trial locations and contacts
1 site in 1 country.
About this study
Physiotherapist research about Sensory rehabilitation in chemotherapy induced peripheral neuropathy (CIPN) with the aid of questioners and physiotherapy practice
- Conditions
- CIPN
- Being tested
- Questionares and practice
- Keywords
- Neuropathic pain, Chemo Induced Peripheral Neuropathy (CIPN), Sensory rehabilitation, Explicit Sensory Retraining
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionares and practiceDiagnostic test
Questionares and practice
| Study group | Role | What they receive |
|---|---|---|
| Explicit sensory retraining for lower extremity in individuals with CIPN | Experimental | Explicit sensory retraining for lower extremity function (pain, sensory, balance, gait). five one-hour sessions, a week apart: Pre-Post assessment sessions with 3 treatment sessions in between. Home exercise assigned. Receives: Diagnostic Test: Questionares and practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNAS
TNAS -Treatment-Induced Neuropathy Assessment Scale. 0-90. higher score = worse status
Measured: 2 years
VAS
0-100 mm visual scale: self-reporting pain assessment from no pain to worst pain possible. We will ask for current pain and the worst pain during the last week.
Measured: 2 years
FABS
Fullerton Advanced Balance Scale: high function balance test - consisting of 10 activities in both static and dynamic phases; 10-40, higher scores are better.
Measured: 2 years
TUG
Timed Up and Go: fall prediction screening test; measures time taken to raise from a chair walking 3 meters and re-sit.
Measured: 2 years
NSA
Nottingham Sensory Assessment: sensory detection and discrimination test
Measured: 2 years
Semmes-Weinstein monofilament testing
tactile detection threshold
Measured: 2 years
LEPT
Lower Extremity Position Test: proprioception detection and quantification
Measured: 2 years
Allodynia
tested by non-painful mechanical stimulation: gentle brushing and monofilament
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Aug 2022
- Primary completion1 Jan 2024
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPNStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Pilot and Feasibility study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Zefat Academic College
- Responsible party
- Principal investigator, Rotem Merose, Assaf-Harofeh Medical Center
- Investigators
- Rotem Merose, Dr., Principal investigator, Assaf Harofee MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382520
- Sponsor's protocol ID
- 0057-22-ASF
- Status last verified
- Dec 2024
- First submitted
- 16 May 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)
- ClinicalTrials.gov ID
- NCT05382520
- Acronym / sponsor ID
- 0057-22-ASF
- Conditions
- CIPN
- Keywords
- Neuropathic pain, Chemo Induced Peripheral Neuropathy (CIPN), Sensory rehabilitation, Explicit Sensory Retraining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Zefat Academic College
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 19 May 2022 (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.
Physiotherapist research about Sensory rehabilitation in chemotherapy induced peripheral neuropathy (CIPN) with the aid of questioners and physiotherapy practice
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Pilot and Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Explicit sensory retraining for lower extremity in individuals with CIPN | Experimental | Diagnostic Test: Questionares and practiceExplicit sensory retraining for lower extremity function (pain, sensory, balance, gait). five one-hour sessions, a week apart: Pre-Post assessment sessions with 3 treatment sessions in between. Home exercise assigned. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 and over who suffer from chemotherapy-induced neuropathy (CIPN), according to the patient's report, more than 3 months since the end of the chemotherapy treatment.
Key exclusion criteria (5 listed)
- Sensory damage / neuropathy that existed even before the start of chemotherapy
- Incidents of recurrent falls even before the start of chemotherapy (over 2 falls for 6 months)
- Central nervous system involvement
- Major pre-morbid orthopedic lower limb impairment
- Hebrew language not sufficient for assessment and treatment
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 |
|---|---|---|
| Questionares and practiceQuestionares and practice | Diagnostic test | Explicit sensory retraining for lower extremity in individuals with CIPN |
Primary outcome
TNAS
Time frame: 2 years
TNAS -Treatment-Induced Neuropathy Assessment Scale. 0-90. higher score = worse status
VAS
Time frame: 2 years
0-100 mm visual scale: self-reporting pain assessment from no pain to worst pain possible. We will ask for current pain and the worst pain during the last week.
FABS
Time frame: 2 years
Fullerton Advanced Balance Scale: high function balance test - consisting of 10 activities in both static and dynamic phases; 10-40, higher scores are better.
TUG
Time frame: 2 years
Timed Up and Go: fall prediction screening test; measures time taken to raise from a chair walking 3 meters and re-sit.
NSA
Time frame: 2 years
Nottingham Sensory Assessment: sensory detection and discrimination test
Semmes-Weinstein monofilament testing
Time frame: 2 years
tactile detection threshold
LEPT
Time frame: 2 years
Lower Extremity Position Test: proprioception detection and quantification
Allodynia
Time frame: 2 years
tested by non-painful mechanical stimulation: gentle brushing and monofilament
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 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for CIPN
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AYUrvedic Foot Massage for Symtoms of Taxane-induced Peripheral nEuroPathy
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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.
Rotem Merose, Dr. principal investigator
Assaf Harofee MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionares and practice in people with CIPN, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 1 inclusion and 5 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 4 Sep 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 Israel. 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?
TNAS (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.