Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy

Sponsor

Riphah International University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05848180

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Peripheral Neuropathy	Other: Ankle proprioceptive training (APT) Other: Balance training (BT)	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

There will be two groups .One is interventional and the other is control group. Interventional group will be taking ankle proprioceptive training and balance training, where control will be having only balance training exercises.There will be two groups .One is interventional and the other is control group. Interventional group will be taking ankle proprioceptive training and balance training, where control will be having only balance training exercises.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The participents of both groups and the outcome assessor will be blinded

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iinterventional group Ankle proprioceptive and balance training 3 days a week for 8 weeks.	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 Other: 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
Active Comparator: control group Balance training 3 days a week for 8 weeks.	Other: 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

Arm

Intervention/Treatment

Experimental: Iinterventional group

Ankle proprioceptive and balance training 3 days a week for 8 weeks.

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

Other: 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

Active Comparator: control group

Balance training 3 days a week for 8 weeks.

Other: 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

Outcome Measures

Primary Outcome Measures

Mini BESTest [Baseline]
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.
Mini BESTest [At 4 weeks]
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.
Mini BESTest [At 8 weeks]
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.
Sharpened Romberg (SR) [Baseline]
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.
Sharpened Romberg (SR) [At 4 weeks]
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.
Sharpened Romberg (SR) [At 8 weeks]
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.
Douleur Neuropathique 4 (DN4) Questionnaire [Baseline]
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.
Douleur Neuropathique en 4 (DN4) Questionnaire [At 4 weeks]
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.
Douleur Neuropathique en 4 (DN4) Questionnaire [At 8 weeks]
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.
Unilateral stance test [Baseline]
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.
Unilateral stance test [At 4 weeks]
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.
Unilateral stance test [At 8 weeks]
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.
The Falls Efficacy Scale International (FES-I) [Baseline]
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.
The Falls Efficacy Scale International (FES-I) [At 4 weeks]
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.
The Falls Efficacy Scale International (FES-I) [At 8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Riphah International University

Investigators

Study Chair: Kiran Khushnood, MSNMPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05848180

Other Study ID Numbers:

RIPHAH/FR&AHS/Letter-014124

First Posted:

May 8, 2023

Last Update Posted:

May 8, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Ankle proprioceptive training

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Diabetic Neuropathies

Study Results

No Results Posted as of May 8, 2023