Effects of Telerehabilitation Versus Clinical Rehabilitation on Chemotherapy Induced Peripheral Neuropathy

NCT06696976 | Not Yet Recruiting DMC

• 1 other identifier: REC/RCR&AHS/24/0229
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the comparative effects of telerehabilitation versus clinical rehabilitation on neuropathic pain, physical function and quality of life in Chemotherapy induced peripheral neuropathy patients.

Conditions

Chemotherapy Induced Peripheral Neuropathy

Keywords

Chemotherapy induced peripheral neuropathy; Telerehabilitation; Quality of life

Outcome Measures

Primary Outcomes (4)

• NUMERIC PAIN RATING SCALE

  Numeric Pain Rating Scale (NPRS) rated CIPN pain. The NPRS is an 11point scale (0-10) ranking pain from 0, indicating no pain at all, to 10, indicating worst pain imaginable on each assessment visit, of the finger tips. This was to identify pain specific to CIPN. A change score of 2 is reported to be a clinically relevant change. The numeric pain rating scale was used for pain measurement , the reliability of which is reported to be between 85% and 95%.

  12th week

• EORTC CIPN20

  The EORTC CIPN20 should provide valuable information on CIPN-related symptoms and functional limitations of patients exposed to potentially neurotoxic chemotherapeutic and/or neuroprotective agents. The resulting 20-item questionnaire was pre-tested in three languages and four countries and is currently being examined in a large, international clinical trial. The Chinese version of the EORTC QLQ-CIPN20 demonstrated acceptable reliability, validity and responsiveness and was found comparable in measuring CIPN among Chinese cancer patients.The questionnaire consists of sensory and motor neuropathy scales, autonomic scales for dizziness, blurred vision, and erectile dysfunction. The results obtained were converted into a 0-100 scale, with higher results indicating a higher degree of peripheral neuropathy.

  12th week

• The Berg balance scale (BBS):

  Is considered the criterion standard in functional balance evaluation. In total, 14 different activities are scored between 0 (worst) and 4 (best), according to the patient's performance. The maximum score is 56. A total score close to 56 indicates that the balance of the patient is good, and lower scores denote poor balance established the validity and reliability of the Turkish version of the BBS.

  12th week

• Manual Muscle testing (MMT)

  Is the most commonly used method for documenting impairments in muscle strength. Because of the variability possible during MMT, several studies examining MMT have used specialized instrumentation to provide support for the extremity tested and for standardization of joint position. Throughout its history manual muscle testing has been performed by practitioners' hands. Lamb states (1985) that MMT has content validity because the test construction is based on known physiologic, anatomic and kinesiologic principles. A number of research papers have dealt with this specific aspect of MMT in the diagnosis of patients.

  12th week

Study Arms (2)

Group A (telerehabilitation of neuropathic pain, physical function and quality of life)

EXPERIMENTAL

Group A will receive Telerehabilitation of 60 minutes with short resting intervals .Treatment will be given 3 times per week for 12 weeks. 1. warm up of 5 minutes 2. Nerve gliding exercises of 10 minutes 3. Balance exercises of 20 minutes 4. Resistance training of 20 minutes 5. cold down of 5 minutes

Other: Telerehabilitation

Group B (clinical rehabilitation of neuropathic pain, physical function and quality of life)

EXPERIMENTAL

Group B will receive Clinical rehabilitation of 60 minutes with short resting intervals .Treatment will be given 3 times per week for 12 weeks. 1. warm up of 5 minutes 2. Nerve gliding exercises of 10 minutes 3. Balance exercises of 20 minutes 4. Resistance training of 20 minutes 5. cold down of 5 minutes

Other: Clinical rehabilitation

Interventions

Telerehabilitation OTHER

A qualified physiotherapist himself used the digital platform Zoom (Zoom Video Communications or WhatsApp video communication) to deliver synchronic online sessions (60 min each), sending each participant a link by email, half an hour before the weekly meetings. The patients were also invited to present themselves in comfortable gymnastic clothing and with tools useful for the motor program: a chair, a stick, a bottle full of water (or small weights if the patient had them), and a mat. Nerve gliding exercises: These 5 Nerve gliding exercises will perform 3 times a week requiring 10 minutes to complete. Balance exercises: Balance exercise include 10 exercises and take 20 minutes of completion, 2minute for each exercise. Resistance training using Thera Band will performed with the presence of the researcher as an instructor.The main upper-extremity movements consisted of chest press, shoulder press etc and in lower extremity such as leg press ,back thgh press etc. in patient.

Group A (telerehabilitation of neuropathic pain, physical function and quality of life)

Clinical rehabilitation OTHER

A qualified physiotherapist himself used the digital platform Zoom (Zoom Video Communications or WhatsApp video communication) to deliver synchronic online sessions (60 min each), sending each participant a link by email, half an hour before the weekly meetings. The patients were also invited to present themselves in comfortable gymnastic clothing and with tools useful for the motor program: a chair, a stick, a bottle full of water (or small weights if the patient had them), and a mat. Nerve gliding exercises: These 5 Nerve gliding exercises will perform 3 times a week requiring 10 minutes to complete. Balance exercises: Balance exercise include 10 exercises and take 20 minutes of completion, 2minute for each exercise. Resistance training using Thera Band will performed with the presence of the researcher as an instructor.The main upper-extremity movements consisted of chest press, shoulder press etc and in lower extremity such as leg press ,back thgh press etc. in patient.

Group B (clinical rehabilitation of neuropathic pain, physical function and quality of life)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Female with breast cancer patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with breast cancer.
• Patients of age between 45 to 75years.
• Patient expected to survive for 6 month or more.
• Patient after specific chemotherapy such as taxanes(paclitaxel),vinca alkaloids(vinorelbine),bortezomib, lenalidomide and platinum-based.
• Patient with Stage 1 to 3.
• Patients have prior history of mechanical nerve entrapment without clinical symptoms (carpal tunnel syndrome) were included.
• Patient who sustained grade 3 and 4 of European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20).

You may not qualify if:

• Patients with history of peripheral neuropathy.
• Participants are excluded if they had comorbid conditions causing peripheral neuropathic symptoms (including previous chemotherapy or diabetes or alcohol abuse and non-alcoholic liver diseases.
• Patients not scheduled for one of the aforementioned taxane-based regimens.
• Patients with vitamin D or B12 deficiency.
• Non-ambulatory Patients.
• Patients reluctant to practice exercise program.
• Patient have impaired visual or vestibular system and presence of bone or any kind of central nervous system involvement , including cancer.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

Location

Related Publications (12)

• Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.

  PMID: 15911236 BACKGROUND

• Cheville AL, Moynihan T, Herrin J, Loprinzi C, Kroenke K. Effect of Collaborative Telerehabilitation on Functional Impairment and Pain Among Patients With Advanced-Stage Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):644-652. doi: 10.1001/jamaoncol.2019.0011.

  PMID: 30946436 BACKGROUND

• Loubani K, Schreuer N, Kizony R. Telerehabilitation for Managing Daily Participation among Breast Cancer Survivors during COVID-19: A Feasibility Study. J Clin Med. 2022 Feb 16;11(4):1022. doi: 10.3390/jcm11041022.

  PMID: 35207294 BACKGROUND

• van Egmond MA, Engelbert RHH, Klinkenbijl JHG, van Berge Henegouwen MI, van der Schaaf M. Physiotherapy With Telerehabilitation in Patients With Complicated Postoperative Recovery After Esophageal Cancer Surgery: Feasibility Study. J Med Internet Res. 2020 Jun 9;22(6):e16056. doi: 10.2196/16056.

  PMID: 32515742 BACKGROUND

• Galiano-Castillo N, Arroyo-Morales M, Lozano-Lozano M, Fernandez-Lao C, Martin-Martin L, Del-Moral-Avila R, Cantarero-Villanueva I. Effect of an Internet-based telehealth system on functional capacity and cognition in breast cancer survivors: a secondary analysis of a randomized controlled trial. Support Care Cancer. 2017 Nov;25(11):3551-3559. doi: 10.1007/s00520-017-3782-9. Epub 2017 Jun 22.

  PMID: 28639097 BACKGROUND

• Cottrell MA, O'Leary SP, Swete-Kelly P, Elwell B, Hess S, Litchfield MA, McLoughlin I, Tweedy R, Raymer M, Hill AJ, Russell TG. Agreement between telehealth and in-person assessment of patients with chronic musculoskeletal conditions presenting to an advanced-practice physiotherapy screening clinic. Musculoskelet Sci Pract. 2018 Dec;38:99-105. doi: 10.1016/j.msksp.2018.09.014. Epub 2018 Oct 4.

  PMID: 30366292 BACKGROUND

• Dhawan S, Andrews R, Kumar L, Wadhwa S, Shukla G. A Randomized Controlled Trial to Assess the Effectiveness of Muscle Strengthening and Balancing Exercises on Chemotherapy-Induced Peripheral Neuropathic Pain and Quality of Life Among Cancer Patients. Cancer Nurs. 2020 Jul/Aug;43(4):269-280. doi: 10.1097/NCC.0000000000000693.

  PMID: 30888982 BACKGROUND

• Zhang YH, Hu HY, Xiong YC, Peng C, Hu L, Kong YZ, Wang YL, Guo JB, Bi S, Li TS, Ao LJ, Wang CH, Bai YL, Fang L, Ma C, Liao LR, Liu H, Zhu Y, Zhang ZJ, Liu CL, Fang GE, Wang XQ. Exercise for Neuropathic Pain: A Systematic Review and Expert Consensus. Front Med (Lausanne). 2021 Nov 24;8:756940. doi: 10.3389/fmed.2021.756940. eCollection 2021.

  PMID: 34901069 BACKGROUND

• Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30.

  PMID: 28963591 BACKGROUND

• Stubblefield MD, McNeely ML, Alfano CM, Mayer DK. A prospective surveillance model for physical rehabilitation of women with breast cancer: chemotherapy-induced peripheral neuropathy. Cancer. 2012 Apr 15;118(8 Suppl):2250-60. doi: 10.1002/cncr.27463.

  PMID: 22488699 BACKGROUND

• Mols F, Beijers T, Vreugdenhil G, van de Poll-Franse L. Chemotherapy-induced peripheral neuropathy and its association with quality of life: a systematic review. Support Care Cancer. 2014 Aug;22(8):2261-9. doi: 10.1007/s00520-014-2255-7. Epub 2014 May 1.

  PMID: 24789421 BACKGROUND

• Bahar-Ozdemir Y, Akyuz G, Kalkandelen M, Yumuk PF. The Effect of Therapeutic Exercises on Balance, Quality of Life, and Pain in Patients Who Were Receiving Neurotoxic Chemotherapy. Am J Phys Med Rehabil. 2020 Apr;99(4):291-299. doi: 10.1097/PHM.0000000000001324.

  PMID: 31592877 BACKGROUND

MeSH Terms

Interventions

Telerehabilitation; Treatment Outcome

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration; Prognosis; Diagnosis; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• Muhammad Kashif, Phd

  Riphah International University

  STUDY CHAIR

Central Study Contacts

Muhammad Kashif, Phd

CONTACT

03333125303; kashif.shaffi@riphah.edu.pk

Ezza Zainab, MS-NMPT

CONTACT

03074008354; ezzazainab9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: November 20, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)