Intervention group for Diabetes

N/A

Waitlist Available

Research Sponsored by Hamad Medical Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female patients with diabetes receiving dialysis who are >40 years old.

Ambulatory (able to independently walk 20m with or without walking assistance).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and12 weeks

Awards & highlights

Study Summary

This trial is proposing the use of plantar electrical stimulation to help improve balance and quality of life in patients with diabetes who are undergoing hemodialysis treatment.

Eligible Conditions

Cardiovascular Complications
Diabetes
Hemodialysis Complication
Quality of Life

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in balance from baseline to 12 weeks

Accidental Falls

Change in gait parameters from baseline to 12 weeks.

+2 more

Secondary outcome measures

Change in cognitive function

Change in depression

Change in pain

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intervention groupActive Control1 Intervention

The intervention group will take part in a 12-week plantar electrical stimulation intervention using the proposed technology 3 times per week during HD either in a sitting or supine position under the supervision of a research staff member. The duration of each treatment session will be one hour. Patients who receive an activated electrical stimulation unit will receive a standard dose of 30 milliamps as described in the following during each HD session (3 times per week for 12 weeks).

Group II: Control groupPlacebo Group1 Intervention

Placebo controls will have an electrical stimulation unit programmed not to provide any electrical current, while all other lights and programming indicators will be functional. Both active and inactive electrical stimulation units will be programmed to download the period that they are used on a weekly basis in order to verify that the units are used for the prescribed time period.

0 / 5Eligibility criteria met