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CompletedNCT05848180Updated Oct 12, 2023

Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy

An interventional study of Ankle proprioceptive training (APT) and Balance training (BT) in Diabetic Peripheral Neuropathy, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-12.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Peripheral Neuropathy

Keywords

  • Diabetes
  • Diabetic neuropathy
  • Balance
  • Risk of fall
  • Ankle proprioceptive training
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 62 is close to the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Iinterventional group

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

    Other: Ankle proprioceptive training (APT) · Other: Balance training (BT)

  • Active comparator
    control group

    Balance training 3 days a week for 8 weeks.

    Other: Balance training (BT)

Interventions

  • OtherAnkle 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

  • OtherBalance training (BT)

    Balance training exercises comprising of side walk, tandem walk, standing on one leg, walking with alternating arm raise up to 90 degrees

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: At 4 weeks

  3. 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.

    Time frame: At 8 weeks

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: At 4 weeks

  6. 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.

    Time frame: At 8 weeks

  7. 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.

    Time frame: Baseline

  8. 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.

    Time frame: At 4 weeks

  9. 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.

    Time frame: At 8 weeks

  10. 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.

    Time frame: Baseline

  11. 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.

    Time frame: At 4 weeks

  12. 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.

    Time frame: At 8 weeks

  13. 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.

    Time frame: Baseline

  14. 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.

    Time frame: At 4 weeks

  15. 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.

    Time frame: At 8 weeks

07

Study locations

1 site
  • Capital developmental authority hospital
    Islamabad, Islamabad Capital Territory 44000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05848180
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
May 8, 2023
Start date
May 5, 2023
Primary completion
Aug 30, 2023
Completion
Sep 30, 2023
Last update
Oct 12, 2023

Study contacts

Kiran Khushnood, MSNMPT
study chair · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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