- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394504
Effects of Turning Based Dual Task Training on Balance and Mild Cognitive Impairment in Diabetic Peripheral Neuropathy
Study Overview
Status
Intervention / Treatment
Detailed Description
Diabetes mellitus (DM) is a chronic metabolic disorder characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. As a major global health concern, its prevalence has been steadily increasing. According to the recent searches, 26.7% of adults in Pakistan are affected by diabetes. Implicated poor glycemic control, duration of diabetes, hyperlipidemia (particularly hypertriglyceridemia), elevated albumin excretion rates and obesity as risk factors for the development of DPN. This study aims to explore the effectiveness of these interventions in this specific population and to tell a treatment that will target both balance and cognition that will be used for DPN patients to improve the symptoms.
A randomized controlled trial will be conducted over one year. 44 participants will be selected through non- probability purposive sampling and randomly divided into two groups. The intervention will last eight weeks, comprising 24 treatment sessions. Assessments will be conducted at baseline and at the end of eight week. Treatment for Group A will include warm up, conventional balance training, turning based dual task training followed by cool down. Group B will include warm up, conventional balance training, dual task training followed by cool down.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Islamabad, Pakistan, 44000
- Foundation University College of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Type 2 Diabetes Mellitus ≥ 5 years
- Diagnosed with Diabetic Peripheral Neuropathy
- Age 50 and above
- Berg Balance Scale (BBS 21-40) score
- Mild Cognitive Impairments (MoCA 18-25)
- Able to stand and walk with or without assistive devices
Exclusion Criteria:
- Severe neuropathic foot ulcers or Charcot joints.
- History of major musculoskeletal injuries affecting ambulation (Fractures of lower limb), Severe Osteoarthritis.
- Uncontrolled Diabetes.
- Neurological disorders unrelated to DPN (brain tumors, stroke, epilepsy, Alzheimer's, GBS and Parkinson's disease).
- Significant visual, auditory impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Turning Based Dual-Task Training
Group A receives Turning Based Dual-Task Training: The intervention will be conducted over a total duration of 8 weeks with total of 24 sessions 3 days per week lasting for 30 to 40 minutes. Warm up, Conventional balance training and cool down. |
Intervention will be of 8 weeks , 24 sessions, three per week, lasting 30-40 minutes. Warm-up exercises followed by cool down. Conventional balance training consisting sitting eyes open/closed, dynamic weight shifting, Static/tandem Standing. Turning protocol will be in three progressive phases. Phase 1 will include turning around cone, obstacles, during walking and 8 figure walk with cognitive dual task( name animals, shapes etc). Phase 2 exercises are 360 turn, sudden turn, stepping with turn, 8 figure turn and obstacle turn with more cognitive load. Phase 3 exercises are all exercises above in tandem walk with reaching activites and more cognitive load. |
|
Experimental: Dual-Task Training
Group B receives Dual-Task Training: The intervention will be conducted over a total duration of 8 weeks with total of 24 sessions 3 days per week lasting for 30 to 40 minutes. Warm up, Conventional balance training and cool down. |
Intervention will be of 8 weeks , 24 sessions, three per week, lasting 30-40 minutes. Warm-up exercises followed by cool down. Conventional balance training consisting sitting eyes open/closed, dynamic weight shifting, Static/tandem Standing. This protocol will be in three progressive phases. Phase 1 will include sit to stand, dynamic weight shifting (standing), stepping, walking in multi direction with cognitive task like name countries, sentence completion etc. Phase 2 will include additional step over low obstacle in walking along the above exercises with more repetitions and increased cognitive load. Phase 3 will include tandem walk, step over high obstacle, ball throw/catch, multi direction walk in tandem with more increased cognitive load respectively. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: 8 weeks
|
Balance is assessed by Berg Balance Scale.
Interpretations: mild=41-56,moderate=21-40,severe=0-20
|
8 weeks
|
|
Cognition
Time Frame: 8 weeks
|
MoCA will be used for mild cognitive impairment.
Interpretations: Mild= 18-25, Moderate=10-17, Severe=0-9
|
8 weeks
|
|
Fall Risk
Time Frame: 8 weeks
|
Timed up and go test will be used for Fall Risk.
Interpretations: Low Risk: <10 seconds, Moderate Risk: 10-19 seconds, High Risk: ≥ 14-20 seconds, Severe Risk: > 30 seconds
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2025/29
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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