NCT04530669

The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Lama Saad El-Din Mahmoud · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To investigate the effect of "High Tone Power Therapy" (HTPT) on fatigue and functional outcomes in multiple sclerosis (MS). BACKGROUND: Fatigue and functional limitations considered serious disorders in patients with multiple sclerosis that lead to impairment of the physical activities and disruption of the quality of life (QOL). HYPOTHESES: This study hypothesized that: High Tone Power Therapy will have a significant beneficial effect on fatigue and functional outcomes in in multiple sclerosis RESEARCH QUESTION: Is there a beneficial effect of High Tone Power Therapy on fatigue and functional outcomes in multiple sclerosis?

Detailed description

Double blind randomized study including 40 patients with MS. The patients will be randomly allocated into 2 arms: active arm and placebo arm; in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program, and the placebo arm will receive the same physical exercise program with sham "high tone power therapy". Either program will be applied 3 times per week for 4 weeks. The evaluation methods will be done using: * Expanded Disability Status Scale (EDSS) / Functional Systems Score (FSS), * Fatigue severity scale and Modified Fatigue Impact Scale. before the exercise program and after finishing the exercise program, The assessor of the patients, before and after the program, will be blinded to the technique used (whether active or sham).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	High Tone Power Therapy	High Tone Power Therapy (HiTop 191): (For group I). The high tone power therapy through using a device (HiTop 191; gbo Medizintechnik, Rimbach, Germany). The intensity of the electrical stimulation will be adjusted to a pleasant level that did not produce any pain or discomfort.
OTHER	exercise program	physical therapy conventional selected exercise program inform of functional activities of daily living

Timeline

• Start date: 2020-09-01
• Primary completion: 2020-10-15
• Completion: 2020-12-30
• First posted: 2020-08-28
• Last updated: 2021-07-13

Locations

1 site across 1 country: Egypt