Influence of weights tied at ankle on balance and leg muscle activity in persons with hemiplegia

Phase 2

Active, not recruiting

• Conditions: Sub-acute and Chronic Stroke

• Registration Number: CTRI/2017/05/008565
• Lead Sponsor: Manipal University

Brief Summary

Patients will be screenedand selected based on the inclusion/exclusion criteria. The selected patientswill be explained in brief about the study procedures and the tests and then aninformed consent will be obtained from them. After briefing them,individual’s demographic details will be recorded, followed by assessment ofthe outcome measures.

The outcome measures, that is, postural swayand lower limb muscle activation will be assessed using Static Posturography(Good Balance system, Metitur Ltd, Jyvaskyla, Finland) and WirelessElectromyography (DELSYS Trigno wireless EMG system, AD instruments, USA. 2016)respectively in the following 4 conditions:

Without weight aboveparetic ankle

-With 0.5 kg weight aboveparetic ankle

-With 1 kg weight aboveparetic ankle

-With 2 kgs weight aboveparetic ankle

The above test sequencewill be randomized using lottery method.

SurfaceEMG electrodes will be applied on the following muscles:

a) Tibialis anterior-over the area of greatest muscle bulk just lateral to the crest of the tibia onthe proximal half of the leg(11)

b) Soleus- on theposterior aspect of the leg, 5 centimeters below the insertion of gastrocnemii(12)

c) Lateral gastrocnemius-over the area of greatest bulk on the lateral calf(11)

d) Medial gastrocnemius-over the area of greatest bulk on the medial calf(11)

Afterapplying the electrodes, the weight cuff corresponding to the weight selectedby the patients will be applied over the paretic ankle and then the patientswill be asked to stand on force plate with their legs spread at shoulder widthand looking straight ahead for 30 seconds. Then postural sway velocity andvelocity moment of subjects in the standing posture will be measured, andsimultaneous in that 30 seconds RMS of the electromyographic signal in mV oftibialis anterior, soleus, lateral gastrocnemius and medial gastrocnemius willbe calculated using a wireless EMG. The outcome measures will be calculatedwith eyes open and eyes closed. Similarly, all the other test conditions willbe done, except for the test condition ‘without weight over paretic ankle’where without any weight cuff on the patient’s paretic ankle the outcomemeasures will be calculated. Rest period of 10 minutes will be provided betweeneach test condition.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-06
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1)Patients with sub-acute or chronic stroke 2)Patients who can stand with or without supervision 3)MMSE- ≥ 24 4)Patients with unilateral stroke 5)People who have had single episode of stroke 6)Functional vision and hearing.

Exclusion Criteria

1)Patients with any musculoskeletal disorders and injury of lower limb 2)Patients who had undergone recent lower extremity surgery 3)Patients with open wounds on ankle 4)Additional neurological or psychiatric disorders 5)Vestibular diseases 6)Uncooperative patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Postural sway using Posturography	4 time points: | Without weight on ankle for 30 seconds | With 0.5 kg weight on ankle for 30 seconds | With 1 kg weight on ankle for 30 seconds | With 2 kg weight on ankle for 30 seconds
- Sway velocities in the mediolateral and in the	4 time points: | Without weight on ankle for 30 seconds | With 0.5 kg weight on ankle for 30 seconds | With 1 kg weight on ankle for 30 seconds | With 2 kg weight on ankle for 30 seconds
anteroposterior directions will be calculated in mm/sec, and	4 time points: | Without weight on ankle for 30 seconds | With 0.5 kg weight on ankle for 30 seconds | With 1 kg weight on ankle for 30 seconds | With 2 kg weight on ankle for 30 seconds
- Velocity moment will be calculated in mm²/sec	4 time points: | Without weight on ankle for 30 seconds | With 0.5 kg weight on ankle for 30 seconds | With 1 kg weight on ankle for 30 seconds | With 2 kg weight on ankle for 30 seconds

Secondary Outcome Measures

Name	Time	Method
1.Weight symmetry using Posturography	2.Muscle activation using wireless EMG

Trial Locations

Locations (1)

Kasturba hospital; 🇮🇳 Udupi, KARNATAKA, India

Kasturba hospital

🇮🇳Udupi, KARNATAKA, India

Priyanka Lalakia

Principal investigator

9036137119

priyanka.lalakia@gmail.com