BRACE(Balance, Resistance, Aerobic and Cognitive Exercise) Protocol for Diabetic).Peripheral Neuropathic Patients.

NCT04832464 | Unknown

• 1 other identifier: REC/00548 Azka Tariq
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the effects of the BRACE( Balance, Resistance, Aerobic and Cognitive Exercise) protocol for balance training in patients with Diabetic Peripheral Neuropathy. A Randomized Control Trial is being conducted at Railways General Hospital, Rawalpindi. The sample size was calculated through the open epi tool. A total of 60 patients are divided into two groups, 30 participants in the experimental group and 30 participants in the control group. The study duration will be six months. The sampling technique applied was simple random sampling for recruitment and group randomization using the sealed envelope method. Patients with the age of 40-65 years having type II diabetes for more than 5 years are included in the study. Tools used in the study are Berg balance scale, timed up and go test, functional reach test, Montreal Cognitive Assessment scale (MOCA), and force plate. Data will be analyzed through Statistical Package for the Social Sciences (SPSS), version 21.

Conditions

Diabetic Peripheral Neuropathy (DPN)

Keywords

Diabetic Peripheral Neuropathy; Balance training; Strengthening; Cognitive exercises; Aerobics exercises

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  To objectively determine a patient's ability (or inability) to safely balance during a series of pre-determined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function with a total of 56 scores. This scale is interpreted as 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents a good balance. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).

  Up to 8 weeks

Secondary Outcomes (6)

• TUG test

  Up to 8 weeks

• FRT test

  Up to 8 weeks

• MoCA

  Up to 8 weeks

• Postural sway

  Up to 8 weeks

• Gait and Posture assessment by application

  Up to 8 weeks

Study Arms (2)

Balance Training Home plan

ACTIVE COMPARATOR

The Control group is undergoing balance training only, 3 days a week, and will be for 8 weeks. Balance training includes 10minutes of warm-up and 30 minutes of balance exercises. A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week). These exercises include Static Balance exercises(1-2weeks): Romberg with eyes open \& close, Tandem standing with eyes open \& close with alternate feet, Single leg stance. Static/ Dynamic/ Anticipatory Postural Control (3-4weeks): Sit to Stand, FRT( forward reach test) that is forward, sideways, cross reach, and timed up and go test. Static/ Dynamic/ Anticipatory? Reactive Postural Control (5-6weeks): Perturbations: Controlled by the therapist in sitting \& standing, Throwing a ball, kicking a ball. (7-8weeks): Combination of All

Other: RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.

BRACE Protocol: Balance training along with resistance, aerobic and cognitive excercises

EXPERIMENTAL

BRACE protocol for balance training 3 days a week for 8 consecutive weeks on alternate days. These exercises include Static Balance exercises(1-2weeks) plus Chair rise 30 sec without using hands, 6-minute walk, count reverse from 50, push the wall, and reverse count from 20. Static, dynamic, anticipatory postural control (3-4weeks) plus Stair climbing without using rails, marching in space, remember 5 words, name 5 animals, repeat 5 words, spell the word like APPLE, spell backward again. Static, dynamic, anticipatory postural control (5-6weeks) plus Squatting, cycling, count even numbers from 1-50. calculation: Addition, subtraction, multiplication, division. (7-8weeks): Combination of all.

Other: RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.

Interventions

RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises. OTHER

therapy for the preservation, enhancement, or restoration of movement and physical function impaired or threatened by disease, injury, or disability that utilizes therapeutic exercise, physical modalities (such as massage and electrotherapy), assistive devices, and patient education and training.

Also known as: Balance Training Home plan

BRACE Protocol: Balance training along with resistance, aerobic and cognitive excercises; Balance Training Home plan

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type-2 Diabetes
• Diabetes of more than 5 years of the duration

You may not qualify if:

• Patients have vertebrobasilar insufficiency (tested by VBI tests)
• Atlanto-axial instability (tested by sharp purser test)
• Osteoporosis
• Rheumatoid arthritis
• Neuropathies
• Recent surgeries

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

RECRUITING

Related Publications (7)

• Pandey S, Raj IJS. Comparison of Game Based Rehabilitation and Mixed Sport Training on Balance in Diabetic Neuropathy: Lovely Professional University; 2017

  BACKGROUND

• American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2013 Jan;36 Suppl 1(Suppl 1):S67-74. doi: 10.2337/dc13-S067. No abstract available.

  PMID: 23264425 BACKGROUND

• O'Sullivan SB, Schmitz TJ, Fulk G. Physical rehabilitation: FA Davis; 2019

  BACKGROUND

• Kluding PM, Bareiss SK, Hastings M, Marcus RL, Sinacore DR, Mueller MJ. Physical Training and Activity in People With Diabetic Peripheral Neuropathy: Paradigm Shift. Phys Ther. 2017 Jan 1;97(1):31-43. doi: 10.2522/ptj.20160124.

  PMID: 27445060 BACKGROUND

• Ahmad I, Hussain E, Singla D, Verma S, Ali K. Balance Training in Diabetic Peripheral Neuropathy: A Narrative Review. JSM Diabetol Manag. 2017;2(1):1-9

  BACKGROUND

• Wallin A, Kettunen P, Johansson PM, Jonsdottir IH, Nilsson C, Nilsson M, Eckerstrom M, Nordlund A, Nyberg L, Sunnerhagen KS, Svensson J, Terzis B, Wahlund LO, Georg Kuhn H. Cognitive medicine - a new approach in health care science. BMC Psychiatry. 2018 Feb 8;18(1):42. doi: 10.1186/s12888-018-1615-0.

  PMID: 29422020 BACKGROUND

• Kiani N, Marryam M, Malik AN, Amjad I. The effect of aerobic exercises on balance in diabetic neuropathy patients. Journal Of Medical Sciences. 2018;26(2):141-5

  BACKGROUND

Study Officials

• Imran Amjad, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

(+92)3324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor and participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 5, 2021
• Study Start: March 30, 2021
• Primary Completion: February 27, 2022
• Study Completion: February 27, 2022
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)