Efficacy of the WalkAide and AFOs for CVA

• ClinicalTrials.gov Identifier: NCT00216320
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Results First Posted: April 19, 2013
• Last Update Posted: April 19, 2013
• Sponsor: Innovative Neurotronics
• Information provided by (Responsible Party): Innovative Neurotronics

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stroke
• Interventions: Device: WalkAide; Device: AFO
• Enrollment: 121

Participant Flow

Recruitment Details	Recruitment took place between May 2005 and December 2008 at 9 Rehabilitation centers in the USA.
Pre-assignment Details

Arm/Group Title	Arm 1: WalkAide	Arm 2: Ankle Foot Orthosis	Arm 3: No Crossover
Arm/Group Description	Subjects started with the WalkAide and crossed over to the AFO after six weeks.	Subjects started with the AFO and crossed over to the WalkAide after six weeks.	Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
Period Title: Phase 1 (Weeks 0 - 6)
Started	43	39	30
Completed	43	35	25
Not Completed	0	4	5
Period Title: Phase 2 (Weeks 6 -12)
Started	43	35	25
Completed	38	31	24
Not Completed	5	4	1

Baseline Characteristics

Arm/Group Title		Arm 1: WalkAide	Arm 2: Ankle Foot Orthosis	Arm 3: No Crossover	Total
Arm/Group Description		Subjects started with the WalkAide and crossed over to the AFO after six weeks.	Subjects started with the AFO and crossed over to the WalkAide after six weeks.	Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.	Total of all reporting groups
Overall Number of Baseline Participants		43	39	30	112
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	43 participants	39 participants	30 participants	112 participants
		57.1 (12.9)	55.6 (11.9)	58.8 (9.8)	57.0 (11.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	43 participants	39 participants	30 participants	112 participants
	Female	7 16.3%	16 41.0%	12 40.0%	35 31.3%
	Male	36 83.7%	23 59.0%	18 60.0%	77 68.8%
Chronicity [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	43 participants	39 participants	30 participants	112 participants
		6.4 (3.8)	6.9 (3.2)	5.8 (3.7)	6.4 (3.6)
		[1] Measure Description: Chronicity refers to the number of years since onset of stroke

Outcome Measures

1. Primary Outcome

Title	Figure 8 Walking Speed Before and After Intervention.
Description	Subjects walked a 10 meter Figure 8 pattern for four minutes at fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks
Time Frame	baseline, 6, 6.2 and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: WalkAide	Arm 2: Ankle Foot Orthosis	Arm 3: No Crossover
Arm/Group Description:	Subjects started with the WalkAide and crossed over to the AFO after six weeks.	Subjects started with the AFO and crossed over to the WalkAide after six weeks.	Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
Overall Number of Participants Analyzed	38	31	24
Mean (Standard Deviation); Unit of Measure: meters/second
Week 0 off condition	.337 (.164)	.312 (.151)	.261 (.182)
Week 6 off condition	.432 (.207)	.377 (.166)	.303 (.195)
Week 0 on condition	.358 (.157)	.368 (.186)	.331 (.203)
Week 6 on condition	.456 (.205)	.428 (.179)	.366 (.205)
Week 6.2 off condition	.446 (.216)	.383 (.162)	.303 (.195)
Week 12 off condition	.467 (.233)	.420 (.171)	.328 (.212)
Week 6.2 on condition	.471 (.219)	.400 (.153)	.366 (.205)
Week 12 on condition	.520 (.236)	.436 (.172)	.388 (.208)

2. Primary Outcome

Title	Physiological Cost Index Before and After Intervention.
Description	PCI is the difference between resting heart rate and active heart rate during walking, divided by average walking speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks
Time Frame	baseline, 6, 6.2 and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: WalkAide	Arm 2: Ankle Foot Orthosis	Arm 3: No Crossover
Arm/Group Description:	Subjects started with the WalkAide and crossed over to the AFO after six weeks.	Subjects started with the AFO and crossed over to the WalkAide after six weeks.	Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
Overall Number of Participants Analyzed	33	27	17
Mean (Standard Deviation); Unit of Measure: beats/minute
Week 0 off condition	.957 (0618)	1.128 (.616)	1.486 (.753)
Week 6 off condition	.824 (.446)	.978 (.698)	1.311 (.720)
Week 0 on condition	.985 (.580)	.903 (.440)	1.163 (.621)
Week 6 on condition	.791 (.411)	.853 (.471)	1.022 (.455)
Week 6.2 off condition	.796 (.484)	.908 (.499)	1.311 (.720)
Week 12 off condition	.712 (.494)	.983 (.662)	1.160 (.823)
Week 6.2 on condition	.726 (.435)	.847 (.400)	1.022 (.455)
Week 12 on condition	.656 (.325)	.972 (.694)	.892 (.481)

3. Primary Outcome

Title	10 Meter Walking Speed Before and After Intervention.
Description	Subjects walked 10 meters at their fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks
Time Frame	baseline, 6, 6.2 and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: WalkAide	Arm 2: Ankle Foot Orthosis	Arm 3: No Crossover
Arm/Group Description:	Subjects started with the WalkAide and crossed over to the AFO after six weeks.	Subjects started with the AFO and crossed over to the WalkAide after six weeks.	Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
Overall Number of Participants Analyzed	38	31	24
Mean (Standard Deviation); Unit of Measure: meters/second
Week 0 off condition	.457 (.245)	.415 (.220)	.361 (.264)
Week 6 off condition	.575 (.291)	.489 (.233)	.428 (.286)
Week 0 on condition	.524 (.253)	.472 (.246)	.438 (.286)
Week 6 on condition	.625 (.309)	.568 (.261)	.500 (.308)
Week 6.2 off condition	.591 (.304)	.486 (.229)	.428 (.286)
Week 12 off condition	.641 (.349)	.564 (.264)	.477 (.296)
Week 6.2 on condition	.645 (.313)	.508 (.223)	.500 (.308)
Week 12 on condition	.730 (.369)	.596 (.278)	.546 (.326)

4. Secondary Outcome

Title	Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO
Description	Subjects in Arm 1 or 2 (who used both devices) were given the option to continue using WalkAide or AFO for additional 12 weeks, their preference was recorded along with reasons for preference
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

per protocol (completers) analysis

Arm/Group Title	Subjects Who Used Both WA and AFO
Arm/Group Description:	Subjects in arm 1 (wore WalkAide for 6 weeks followed by AFO for 6 weeks) and arm 2 (wore AFO for 6 weeks followed by WalkAide for 6 weeks)were given the option of continuing for 12 more weeks with their choice of device
Overall Number of Participants Analyzed	64
Measure Type: Number; Unit of Measure: participants
	45

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects Who Used Both WA and AFO
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Arm 1		Arm 2		Arm 3
Arm/Group Description	All subjects used WalkAide for the first 6 weeks and AFO for the second six weeks.		All subjects used AFO for the first 6 weeks and WalkAide for the second six weeks.		All subjects used AFO for all 12 weeks of study.
All-Cause Mortality
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/43 (2.33%)		1/39 (2.56%)		1/30 (3.33%)
Cardiac disorders
Heart surgery † [1]	0/43 (0.00%)	0	0/39 (0.00%)	0	1/30 (3.33%)	1
Death † [2]	1/43 (2.33%)	1	0/39 (0.00%)	0	0/30 (0.00%)	0
Musculoskeletal and connective tissue disorders
Wrist Fracture † [3]	0/43 (0.00%)	0	1/39 (2.56%)	1	0/30 (0.00%)	0
† Indicates events were collected by systematic assessment; [1] Had emergency heart surgery 9/15/06; [2] began experiencing symptoms, went to ER and was admitted for an acute MI. Patient was discharged from the hospital and scheduled for heart surgery to remove blockage. However he then passed away suddenly, before the surgery was done; [3] Pt fell and fractured wrist. Subject was in teh AFO phase of Arm @ but was not wearing a study device at the time
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/43 (16.28%)		5/39 (12.82%)		1/30 (3.33%)
General disorders
Lost consciousness † [1]	1/43 (2.33%)	1	0/39 (0.00%)	0	0/30 (0.00%)	0
weakness and fatigue † [2]	0/43 (0.00%)	0	1/39 (2.56%)	1	0/30 (0.00%)	0
Injury, poisoning and procedural complications
Fall † [3]	2/43 (4.65%)	2	2/39 (5.13%)	2	1/30 (3.33%)	1
Ankle sprain † [4]	1/43 (2.33%)	1	0/39 (0.00%)	0	0/30 (0.00%)	0
Musculoskeletal and connective tissue disorders
LE swelling † [5]	1/43 (2.33%)	1	0/39 (0.00%)	0	0/30 (0.00%)	0
Shoulder surgery † [6]	0/43 (0.00%)	0	0/39 (0.00%)	0	1/30 (3.33%)	1
Respiratory, thoracic and mediastinal disorders
Sinus condition † [7]	0/43 (0.00%)	0	0/39 (0.00%)	0	1/30 (3.33%)	1
Skin and subcutaneous tissue disorders
Skin Irritation electrodes † [8]	4/43 (9.30%)	7	3/39 (7.69%)	4	0/30 (0.00%)	0
Skin irritation AFO †	2/43 (4.65%)	2	0/39 (0.00%)	0	0/30 (0.00%)	0
† Indicates events were collected by systematic assessment; [1] Pt lost consciousness in Physical Therapy, no reason was reported; [2] Subject was weak and fatigued, required bedrest; [3] tripped and fell; [4] sprained ankle getting out of bed; [5] Subject complained of swelling not previously noted; [6] Subject had surgery for rotator cuff tear; [7] subject missed visit due to sinus infection; [8] Irritation from electrodes used with WalkAide

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Director of Clinical Research
• Organization: Innovative Neurotronics
• Phone: 512-721-1922
• EMail: hrogers@ininc.us

Publications of Results:

Everaert DG, Stein RB, Abrams GM, Dromerick AW, Francisco GE, Hafner BJ, Huskey TN, Munin MC, Nolan KJ, Kufta CV. Effect of a foot-drop stimulator and ankle-foot orthosis on walking performance after stroke: a multicenter randomized controlled trial. Neurorehabil Neural Repair. 2013 Sep;27(7):579-91. doi: 10.1177/1545968313481278. Epub 2013 Apr 4.

• Responsible Party: Innovative Neurotronics
• ClinicalTrials.gov Identifier: NCT00216320
• Other Study ID Numbers: WalkAide Trials
• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Results First Submitted: April 18, 2013
• Results First Posted: April 19, 2013
• Last Update Posted: April 19, 2013