Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

Effect Of Ankle Proprioceptive Training On Balance And Risk Of Fall In Patients With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05848180
• Other study ID #: RIPHAH/FR&AHS/Letter-014124
• Status: Completed
• Phase: N/A
• Start date: May 5, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diabetes being a very prevalent condition results in various complications including neuropathy, which can impair various functional outcomes in patients including balance. Ankle proprioceptive training (APT) is an intervention that is used to tackle this problem. The study will compare APT with standard balance training in subjects with diabetic neuropathy.

Description:

The study will include the diagnosed diabetic subjects with score of 4 or more on Douleur neuropathique 4 questionnaire (DN4Q). The subjects will be randomly divided into 2 groups; interventional group and control group. Interventional group will receive APT 3 days a week for 8 weeks. Balance training exercises will be given to both groups 3 days a week for 8 weeks. The assessments will be done at baseline, after 4 weeks and after 8 weeks of interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• Known case of diabetic peripheral neuropathy (DPN),

• Patients who met the criteria of DN4 scored equal or greater than 4.

• Patients who have positive SHARPEND ROMBERG TEST

Exclusion Criteria:

• Patients with DVT

• orthostatic hypotension

• Any recent surgery of lower limb

• Amputies

• Patients with crutches or walking aids

• Patients with gangrene

• Lower BMI

• Acute systemic illness

• Vestibular impairment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• Ankle proprioceptive training (APT)
APT comprise of exercises including towel curls, uni-leg stance on foam with activity, writing alphabets on gym ball with toes, picking marbles with toes. BT includes tendem walk, side leg raises, sit to stand, side walk, back leg raise
• Balance training (BT)
Balance training exercises comprising of side walk, tandem walk, standing on one leg, walking with alternating arm raise up to 90 degrees

Locations

Country	Name	City	State
Pakistan	Capital developmental authority hospital	Islamabad	Islamabad Capital Territory

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini BESTest	Mini BESTest is a 27-item physical performance test that distributes the items among the six sub-systems of static and dynamic balance, including stability limits/verticality, biomechanical constraints, anticipatory postural adjustments, postural responses, sensory orientation and stability in gait.	Baseline
Primary	Mini BESTest	Mini BESTest is a 27-item physical performance test that distributes the items among the six sub-systems of static and dynamic balance, including stability limits/verticality, biomechanical constraints, anticipatory postural adjustments, postural responses, sensory orientation and stability in gait.	At 4 weeks
Primary	Mini BESTest	Mini BESTest is a 27-item physical performance test that distributes the items among the six sub-systems of static and dynamic balance, including stability limits/verticality, biomechanical constraints, anticipatory postural adjustments, postural responses, sensory orientation and stability in gait.	At 8 weeks
Primary	Sharpened Romberg (SR)	The Sharpened Romberg (SR) has been proposed as a quick screening tool for balance. SR requires the client to stand in tandem, with the heel of one foot touching the toe of the other foot, for 30 or 60 seconds.	Baseline
Primary	Sharpened Romberg (SR)	The Sharpened Romberg (SR) has been proposed as a quick screening tool for balance. SR requires the client to stand in tandem, with the heel of one foot touching the toe of the other foot, for 30 or 60 seconds.	At 4 weeks
Primary	Sharpened Romberg (SR)	The Sharpened Romberg (SR) has been proposed as a quick screening tool for balance. SR requires the client to stand in tandem, with the heel of one foot touching the toe of the other foot, for 30 or 60 seconds.	At 8 weeks
Primary	Douleur Neuropathique 4 (DN4) Questionnaire	The Douleur Neuropathique 4 (DN4) Questionnaire is a screening tool for neuropathic pain that includes physical exams and 10 interview questions (DN4-interview). As referred in its original version scores lower than 4 were defined negative and 4 or more as positive.	Baseline
Primary	Douleur Neuropathique en 4 (DN4) Questionnaire	The Douleur Neuropathique 4 (DN4) Questionnaire is a screening tool for neuropathic pain that includes physical exams and 10 interview questions (DN4-interview). As referred in its original version scores lower than 4 were defined negative and 4 or more as positive.	At 4 weeks
Primary	Douleur Neuropathique en 4 (DN4) Questionnaire	The Douleur Neuropathique 4 (DN4) Questionnaire is a screening tool for neuropathic pain that includes physical exams and 10 interview questions (DN4-interview). As referred in its original version scores lower than 4 were defined negative and 4 or more as positive.	At 8 weeks
Primary	Unilateral stance test	Unilateral stance test is used for postural stability. The participant must stand unsupported on one leg. Participants are more likely to fall hurt if they can't maintain the one-leg position for at least five seconds.	Baseline
Primary	Unilateral stance test	Unilateral stance test is used for postural stability. The participant must stand unsupported on one leg. Participants are more likely to fall hurt if they can't maintain the one-leg position for at least five seconds.	At 4 weeks
Primary	Unilateral stance test	Unilateral stance test is used for postural stability. The participant must stand unsupported on one leg. Participants are more likely to fall hurt if they can't maintain the one-leg position for at least five seconds.	At 8 weeks
Primary	The Falls Efficacy Scale International (FES-I)	The Falls Efficacy Scale International (FES-I) measures people's fear about falling. FES-I scores ranging from minimum 7 (no concern about falling) to maximum 28 could be used as a rapid screening tool to evaluate a person's self-reported fear of falling.	Baseline
Primary	The Falls Efficacy Scale International (FES-I)	The Falls Efficacy Scale International (FES-I) measures people's fear about falling. FES-I scores ranging from minimum 7 (no concern about falling) to maximum 28 could be used as a rapid screening tool to evaluate a person's self-reported fear of falling.	At 4 weeks
Primary	The Falls Efficacy Scale International (FES-I)	The Falls Efficacy Scale International (FES-I) measures people's fear about falling. FES-I scores ranging from minimum 7 (no concern about falling) to maximum 28 could be used as a rapid screening tool to evaluate a person's self-reported fear of falling.	At 8 weeks