- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07773922
Otago Exercise Program in Chemotherapy Induced Peripheral Neuropathy
Impact of Otago Exercise Program on Muscle Weakness in Patients With Chemotherapy Induced Peripheral Neuropathy
Forty-eight participants between the age of 35 to 55years patient treated with Taxane chemotherapy, will be randomly divided into two equal groups, each comprising 24 patients.
- Group (A): Consists of twenty- four patients have chemo therapy Induced peripheral Neuropathy and will receive Otago exercise plus resistance exercise 3times per week for 8weeks
- Group (B): Consists of twenty- four patients with Chemotherapy induced peripheral Neuropathy who will receive conventional physical therapy program including: resistance exercise for 8weeks , 3 times per week.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Subject:
Forty-eight participants between the age of 35 to 55years patient treated with Taxane chemotherapy, will be randomly divided into two equal groups, each comprising 24 patients.
- forty-eight patient, will be assigned to two equal matched groups randomly:(twenty-four patient for each group)
- Group (A): Consists of twenty- four patients have chemo therapy Induced peripheral Neuropathy and will receive Otago exercise plus resistance exercise 3times per week for 8weeks
- Group (B): Consists of twenty- four patients with Chemotherapy induced peripheral Neuropathy who will receive conventional physical therapy program including: resistance exercise for 8weeks, 3 times per week.
- Equipments
(1)Therapeutic equipment and tools:
(1)(a)Otago Exercise Program: The session started with a moderate warm-up for joint mobility and flexibility, followed by strengthening exercises for the hips, knees and ankles. Balance activities, including walking and stance challenges, came next, and the session ended with a normal-paced walk and cool-down. All exercises were adapted to participants' ability levels.
- (b)- Therabands for resistance Elastic bands provide a safe and effective method for improving physical function and muscle strength. The findings highlight the importance of power-resistance training and improving quality of life. Elastic bands are emphasized as a low-cost, practical option for seniors to perform resistance training.
- Measurement procedure:
2-(a) Hand Held Dynamometer(HHD):
A Hand-Held Dynamometer (HHD) is a portable device used to measure muscle strength objectively. It measures the maximum force a muscle or muscle group can generate during an isometric contraction.It is commonly used in:
Physical therapy, Rehabilitation, Sports medicine and Clinical research.The examiner places the device against the patient's limb while the patient pushes as hard as possible against it. The device records the peak force produced by the muscle.Depending on the device, results may be displayed in:Newtons (N), Kilograms-force (kgf or kg) or Pounds-force (lbf or lb).
(2)(b)Modified Total Neuropathy Score (mTNS) is a clinical assessment tool used to evaluate the severity of peripheral neuropathy, particularly in patients with Chemotherapy-Induced Peripheral Neuropathy (CIPN). It is a modified version of the Total Neuropathy Score (TNS) that is simpler and more practical for clinical and research use because it does not require nerve conduction studies.The mTNS typically assesses: Sensory symptoms (e.g., numbness, tingling, pain),Motor symptoms (e.g., muscle weakness),Pin sensibility,Vibration sensibility,Muscle strength and deep tendon reflexes.Each item is scored from 0 (normal) to 4 (severe impairment).
Individual scores are added to obtain the total mTNS score.Higher scores indicate more severe peripheral neuropathy.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Egypt
-
Giza, Egypt, Egypten, 12613
- 1 Gamma street ,Giza, Egypt -postal code:12613
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Adults aged 35-55 years. Patients undergoing taxane chemotherapy. Diagnosed with chemotherapy-induced peripheral neuropathy (CIPN). Able to understand and follow assessment and treatment instructions. Willing to provide written informed consent.
Exclusion Criteria:
- Pre-existing neurological disorders (e.g., multiple sclerosis, stroke, or Parkinson's disease).
Symptomatic heart disease, including congestive heart failure, arrhythmia, or myocardial infarction within the previous 3 months.
Severe orthopedic conditions, fractures, or chronic debilitating diseases limiting participation in the exercise program.
Psychological, cognitive, or emotional disorders affecting participation. Uncooperative patients or those unable to follow the exercise protocol. Refusal or inability to provide informed consent
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Otago Exercise Plus Resistance Exercise
Participants will receive the Otago Exercise Program in addition to resistance exercises using elastic bands, three sessions per week for 8 weeks.
|
An individualized Otago Exercise Program including warm-up, lower limb strengthening, balance, walking, and flexibility exercises.
The program is delivered three times per week for 8 weeks under the supervision of a physical therapist.
|
|
Aktiv komparator: Resistance exercises
Participants will receive a conventional physical therapy program including resistance exercises with elastic bands, strengthening exercises, and lower limb exercises, three sessions per week for 8 weeks.
|
resistance exercises with elastic bands, strengthening exercises, and lower limb exercises, three sessions per week for 8 weeks.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Muscle strength of the lower limb muscles will be assessed using a Hand-Held Dynamometer (HHD).
Tidsram: Baseline and after 8 weeks
|
Muscle strength of the lower limb muscles will be assessed using a Hand-Held Dynamometer (HHD).
|
Baseline and after 8 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Modified Total Neuropathy Score (mTNS)
Tidsram: Baseline and after 8 weeks
|
Chemotherapy-induced peripheral neuropathy severity will be assessed using the Modified Total Neuropathy Score (mTNS).
|
Baseline and after 8 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Cairo University, Faculty of Physical Therapy
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Muskuloskeletala sjukdomar
- Sjukdomar i nervsystemet
- Muskelsjukdomar
- Neuromuskulära manifestationer
- Patologiska processer
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Muskelsvaghet
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Terapeutik
- Fysioterapimetoder
- Patientvård
- Träningsterapi
- Rehabilitering
- Eftervård
- Kontinuitet i patientvård
- Fysisk konditionering, mänsklig
- Utöva
- Motståndsträning
Andra studie-ID-nummer
- OTAGO-CIPN-P.T.REC/012/006339
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