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Oxaliplatin-induced chronic peripheral neuropathy is of major concern to oncologists and patients as it has been shown to affect patients' health-related quality of life. Although a number of interventions have been implicated, none of them can be recommended for clinical use. This therapeutic failure reflects a poor understanding of the real mechanism of oxaliplatin-induced neuropathy. However, oxidative stress is identified to be one of the main biomolecular dysfunctions in this neuropathy. Rood's approach is a neurophysiological approach that is based on reflexes of the central nervous system in which the sensory stimulation provides desired muscular response and was specially designed for patients with motor control problems. It was developed by Margeret Rood in 1940. According to Rood, sensory stimulation can activate or deactivate the receptor by facilitation or inhibition, which makes it possible to get the desired muscular response.
So, the purpose of the study is to investigate the efficiency of Rood's approach on oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rood's approach group | Active Comparator | Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy. |
|
| Traditional physical therapy program group | Active Comparator | Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rood's approach | Other | Patients will receive Rood's approach includes various facilitatory and inhibitory techniques. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NCT-CTCAE peripheral neuropathy grading | It consists of of 5 grades; Grade (1) is asymptomatic may be accompanied by loss of tendon reflex or paraesthesia. Grade (2) is moderate symptoms which limit instrumental activities of daily life Grade (3) is severe symptoms which limit self-care activates of daily life. Grade (4) is life threatening consequences or urgent intervention indicated. Grade (5) is death. | Change from baseline at twelve weeks after the intervention |
| The Ntx-12 questionnaire | It is comprised of 12 statements intended to measure the severity and impact of peripheral sensory neuropathy on patients' lives. Patients were instructed to complete the Arabic version of the Ntx-12 and choose the number corresponding to how true each statement was for them using a Likert-type scale, with 0 indicating not at all; 1, a little bit; 2, somewhat; 3, quite a bit; and 4, very much. | Change from baseline at twelve weeks after the intervention |
| Brief Pain Inventory Short Form (BPI-SF) Bworst pain | The BPI-SF assesses pain at its worst, least, average, and now (current pain). Patients respond on 0-to-10 numerical rating scales. Each scale presented as a row of equidistant numbers, where 0 = no pain^ and 10 = pain as bad as you can imagine. | Change from baseline at twelve weeks after the intervention |
| Total Neuropathy Score | used to measure these constructs. It includes 6 items graded from 0 to 4 according to the patients' symptoms, the total grade from 0 to 24. The higher grade the worse neuropathy. It graded as mild (1:9), moderate (10:19) and (20:24) severe. | Change from baseline at twelve weeks after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The 4-Stage Balance Test | is a recommended measure from the Centers for Disease Control and Prevention STEADI (Stopping Elderly Accidents, Deaths, and Injuries) falls campaign to recognize fall risk. An adult who cannot hold tandem stance for 10 seconds is at a higher risk for falls. [18] Patient A was able to stand in tandem stance for 2 seconds on each side. Patient B was able to stand on single leg stance for 10 seconds on each side |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaimaa MA El Sayeh, PhD | Contact | +201007766160 | sh.sayeh87@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shaimaa MA El Sayeh, PhD | Lecturer at Faculty of Physical Therapy, Cairo University | Principal Investigator |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Sixty Patients with colorectal cancer have oxaliplatin-induced peripheral neuropathy. will be indiscriminately assigned to two groups.
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| Traditional physical therapy program | Other | Participants will be engaged in aerobic exercises and balance training, three times per week for twelve weeks. |
|
| Change from baseline at twelve weeks after the intervention |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |